The Business Cocktail

Merck sells biosimilars business to Fresenius

Merck has divested its biosimilars business to fellow German drug maker Fresenius in a deal potentially worth 670 million euros. The drug maker said the move is aligned with a strategy of focusing on innovative medicines while enabling it to exploit its biosimilars portfolio – which is focused on cancer and anti-inflammatory medicines – to full potential. Merck will bank an upfront fee of 170 million euros and milestone payments of up to 500 million euros under the deal, as well as royalties on future product sales. The parties have also agreed to enter into supply and services agreements, which include drug development support and manufacturing services. Separately, Fresenius also announced its intent to buy US generic drug maker Akorn for $4.75 billion.

AbbVie’s PARP inhibitor fails in Phase III trials

AbbVie’s experimental PARP inhibitor veliparib has failed to meet key targets in two late-stage studies testing its potential in lung and breast cancer. The studies were assessing veliparib in combination with the chemotherapy regimen carboplatin and paclitaxel in patients with squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC). In the lung cancer trial, the primary endpoint was improvement in overall survival in a group of patients who had smoked within the past 12 months and had more than 100 smoking events in their lifetime. In the breast cancer study, the primary endpoint was complete pathologic response to treatment, while secondary endpoints included breast conservation rate, overall survival and event-free survival.

Pharma heads call for decision on EMA relocation

Pharma chiefs in Europe are calling on heads of state to reach a prompt decision on the new location for the European Medicines Agency, which is to depart from the UK as a result of Brexit. The Agency was set up in 1995 to act as a central point for the evaluation and monitoring of medicines for member states and countries in the European Economic Area. In an open letter on its proposed relocation, the region’s pharmaceutical industry heads of research and the European Federation of Pharmaceutical Industries and Associations (EFPIA) stress that “it is a stark and alarming reality that such fundamental activities would undoubtedly be impeded were the operations of the agency to be disrupted as a result of the United Kingdom’s exit from the EU. To put it concisely: in the event of obstruction or failure, Europe possesses no backup option.”

Biogen looks to M&A to overcome competition to its MS franchise

With its multiple sclerosis medications under pressure, Biogen is looking to M&A to boost its future. It hopes to do deals that would build on the success it’s enjoyed with neurology drugs, while also looking at new areas, like it did with its new and pricey rare-disease drug Spinraza. Biogen kicked its efforts off this month when it agreed to pay Bristol-Myers Squibb $300 million upfront and up to $410 million in milestones to get its hands on BMS-986168, an anti-tau antibody seen as a treatment for progressive supranuclear palsy (PSP) and Alzheimer’s disease. In addition to supplementing its neurology expertise, the Cambridge, Massachusetts-based biotech is looking at buying some pipeline help in the areas of eye diseases and chronic pain. He pointed at Biogen’s late 2016 approval of Spinraza, a treatment for the lethal muscle disease spinal muscular atrophy as an example of what it might do.

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Prescription drug supply shortages fuel price hikes, new research shows

According to research published by the New England Journal of Medicine and reported by the Wall Street Journal, shortages of prescription drug supplies in the U.S. in recent years resulted in price increases for some drugs. In 2014 and 2015, a shortfall of the bladder-cancer drug BCG triggered a sharp increase in prices for mitomycin, a less effective alternative, according to research published online in the medical journal last week. Mitomycin, a generic produced by Accord Healthcare, saw its price for a single vial nearly double to $869.59 in the summer of 2014 following reports of the BCG shortage. The price for a lower dose of mitomycin jumped 146% to $165.60 during the same period. The shortage of BCG continued into 2015 due to manufacturing quality problems with Sanofi and Merck, driving the costs for mitomycin to $1,415 for the high-dose vial and $272.46 for the lower dose, the research indicated.

Fujifilm invests $116M in U.S. as it races competitors for biologics contract work

Japan’s Fujifilm is relatively new to the drug manufacturing realm and has yet to crack $1 billion in sales from its small-molecule operations. But it believes it can grow exponentially by concentrating on biologic drug production and is investing close to $130 million in plants in the U.S. and U.K. to make that happen. Fujifilm Diosynth Biotechnologies has now completed a $93 million Texas manufacturing facility it acquired several years ago, the company announced Tuesday. But with contracts for work rolling in, Fujifilm said it will invest another $23 million to expand that operation, as well as spend about $9 million on its facilities in Billingham, U.K. All of this is with the goal of hitting about $1 billion in biologics contract work by 2023 as it races competitors to capture the burgeoning biologics CDMO business.

Cobra Biologics to pump $19M into its U.K. and Swedish production facilities

Cobra Biologics will inject $19 million into facilities located in the U.K. and Sweden to help the CDMO meet increased demand from gene and immunotherapy companies. The expansion is expected to take place over a two-year period to support the company’s R&D activities in developing faster and more cost-effective viral vector and DNA plasmid production platforms. The first phase is slotted for its plant in Keele, England, and will expand the facility’s viral vector phase 3 and commercial manufacturing capabilities. Phase two is scheduled for its plants in Matfors and Södertälje, Sweden, to double the capacity for high-quality DNA plasmid production and characterization, which is used by CAR T-cell therapy companies targeting acute lymphoblastic leukemia and chronic lymphocytic leukemia to support early clinical phase adeno-associated virus and lentivirus production. The last phase will expand Cobra’s clinical and commercial capabilities for GMP DNA production.

The world’s most pricey drugs, from a $1.2M gene therapy to a $450K lymphoma med

When Biogen announced the price on its new rare disease drug Spinraza—$750,000 the first year and $375,000 after that—critics popped up immediately. Biogen and its partner Ionis saw their shares drop. Since then, despite the complaints, analysts have raised their expectations for the drug, based on conversations with doctors and payers. But the pricing questions linger, if only in the context of the public debate—and political pushback—pharma’s been facing on its price-setting and price hikes for more than a year now. In a recent accounting of the world’s most expensive drugs, compiled by Reinsurance Group of America, the ranking includes some familiar faces farther down the list—Alexion’s Soliris, for instance, in sixth place at $542,640—and some less-familiar brands as well.

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Cancer, diabetes and eczema star in 2017 top-launch list

Launch prognostications are getting more attention than ever as they come out with “Drugs to Watch” list, and the highlights of different drugs shows what might work this year. By 2021, some of the drugs in the list are expected to bring in $16 billion, shared among Big Pharma and a few top biotechs. Some of the usual suspects are Roche’s Ocrevus; Sanofi and Regeneron’s Dupixent; AstraZeneca’s durvalumab; Novo Nordisk’s semaglutide; Tesaro’s niraparib, just approved as Zejula; Novartis’ LEE011, a.k.a. ribociclib, approved last month under the Kisqali brand name; and Kite Pharma’s KTE-C19, which could be the first-ever CAR-T therapy for cancer. Dupixent, approved last month for moderate-to-severe atopic dermatitis (eczema), came in second with $2.8 billion.

AbbVie’s Humira needs a discount, ICER says, warning Lilly, Sanofi to price with care

The best-selling drug in the world isn’t worth its current price—and isn’t as good at its job as two of its potential competitors. That’s the conclusion of the Institute for Clinical and Economic Review, a cost-effectiveness watchdog, which evaluated rheumatoid arthritis drugs and found AbbVie’s Humira wanting. AbbVie takes issue with the assessment, and it’s unlikely to have much impact on Humira’s hefty sales, at least for now. It might, however, affect pricing decisions on forthcoming novel meds—and the case for those novel meds with payers. It might also affect pricing on Humira biosimilars when they make their debut, and AbbVie’s competitive stance when that happens. Overall, ICER found that immune-modulating RA drugs, from TNF-alpha inhibitors onward, work better than older therapies such as methotrexate. Pricing, however, earned a lower grade under quality-adjusted life year (QALY) analysis.

Debt-laden Teva, looking for cash, weighs $2B women’s health sale

In the wake of CEO Erez Vigodman’s departure, Teva execs have been reviewing the company’s business. And when it comes to what belongs on the chopping block, they may have reached their first conclusion. The company is weighing a sale of its women’s health unit. The generics giant has brought on Morgan Stanley to help it find a buyer, and it’s looking to start the sale process early next month, the news service said. Such a transaction could drum up about $2 billion, which could take a bite out of Teva’s hefty debt load. Teva picked up the division from Merck KGaA’s Merck Serono for €265 million in 2010. But a few years ago, the company put the kibosh on R&D there to channel funds toward other projects, Globes notes.

Fresenius in buyout talks with Akorn in bid to boost sterile injectables unit

Growth in the generic sterile manufacturing industry has spawned a series of big buyouts in the last few years, and Germany’s Fresenius is looking to M&A to build its expertise with a potential deal for a U.S.-based player. Both Fresenius and Lake Forest, Illinois-based Akorn have confirmed they are in discussions, pointing out that there is no guarantee a deal will be finalized. Shares of Akorn closed up more than 18% at $29.77 on the news Friday and were up again today in premarket trading, pushing its market cap to $3.7 billion. Shares still remain far below the $56 a share at which they traded two years ago before accounting problems tied to its buyout of Hi-Tech Pharmacal and other producers gut-kicked its share price.

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Valeant’s asset-sale woes continue as Stada, Mundipharma lowball iNova bids

Embattled Valeant has promised its investors $8 billion in asset sales—but as the company’s latest deal struggles continue to demonstrate, getting there may not be so easy. The bids rolling in for Valeant’s Australian iNova subsidiary aren’t quite up to expectations, with a private equity consortium comprising The Carlyle Group and Pacific Equity Partners, as well as fellow drug makers Mundipharma and Stada, each launching offers of around $900 million. Now, the Review says, Valeant is weighing whether to hang onto iNova—which sells products ranging from weight-loss drug Duromine to asthma treatment Qvar—after the Goldman Sachs-run sales process. Late last year, Valeant also reportedly tried to sell its underperforming GI unit, Salix, to Japan’s Takeda, but talks on a $10 billion deal ultimately fell through over price.

Sanofi Pasteur coughs up $19.8M to settle claims it overbilled the VA

Sanofi Pasteur agreed to pay more than $19.8 million to settle allegations that it overcharged the Department of Veterans Affairs for its products. The French pharma’s vaccines unit voluntarily reported the “calculation and reporting error” with the VA in 2012, and has since “cooperated fully and negotiated in good faith with the government,” according to a statement from the company. Sanofi Pasteur based its first disclosure to the U.S. government on products sold to the VA from 2007 to 2011. A follow-up investigation by the VA’s Office of Inspector General found the overcharging error dated back to 2002, the DOJ said in a statement. Sanofi said that, for some products, the miscalculation led to a lower price to the VA. The company will not seek reimbursement for those undercharges, it said. Neither the DOJ nor Sanofi identified the products involved.

With key rollouts looming, Sanofi’s Genzyme chief Meeker hands over the helm

As Sanofi gears up its biggest launch of the year, the Genzyme chief tasked with overseeing that rollout is leaving the company. David Meeker, CEO of the U.S.-based Sanofi unit and EVP overall, will exit as of June, with Bill Sibold—Sanofi Genzyme’s head of multiple sclerosis, oncology and immunology—taking his place. Sibold’s ascendance comes as Sanofi Genzyme grows in importance for the France-based drug maker. Pegged as one of the company’s “growth platforms” from the days after ex-CEO Chris Viehbacher engineered the acquisition, Genzyme is shouldering an even bigger load now. It’s another in a series of executive changes at Sanofi as well, as CEO Olivier Brandicourt, who took the helm in February 2015, shuffles his team and the divisions they lead.

India’s Alkem says the FDA has approved upgrade plans for cited API plant

After a year of nothing but bad news about FDA citations of its plants, India’s Alkem Laboratories has announced something positive. The Indian drugmaker said that the FDA has issued an Establishment Inspection Report, signing off on Alkem’s plans to upgrade operations at its API plant in Ankaleshwar, India. The plant had been cited with a Form 483 with three observations during a visit by the FDA in December. The drugmaker has 14 manufacturing sites in India and the FDA has been doing a series of inspections after being alerted to problems by U.K. regulators who claimed the drugmaker had used fake data in clinical trials of an unspecified antibiotic and brain disorder drug. That alert came after the FDA had serious issues with Alkem shipping unapproved drugs to the U.S.

GSK recalling nearly 600,000 Ventolin inhalers in U.S.

With sales of its respiratory drugs doing well, GlaxoSmithKline has been spending hundreds of millions of dollars to expand manufacturing of several kinds of inhalers. But a glitch at one of its Ventolin inhaler plants has resulted in recalling nearly 600,000 units in the U.S. According to an FDA Enforcement Report, GSK recently began recalling 593,088 Ventolin inhalers after discovering that an elevated number of the units were out of specification for leak rate, the company reported. The units were manufactured at its plant in Zebulon, North Carolina. A GSK spokesperson pointed out this was not a consumer level recall, so patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level so products are being removed from those channels.

 

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Mylan closing Illinois plant, cutting 90 jobs as part of slim-down after Meda buyout

Mylan has been in the midst of cutting about 3,500 jobs to decrease costs and refocus after its $7 billion buyout last year of Meda Pharmaceuticals. About 90 of those cuts will come with the closure of a plant in Illinois.The drugmaker will shutter a small plant in Decatur, Illinois, that it picked up last year in buyout of Sweden’s Meda, a company that came with about 4,500 employees. A spokesperson said the Decatur plant, which makes a variety of products such as pain med Soma and multivitamin Geritol, will be phased out over several months and the final closure will be in 2018. Mylan has already closed the Meda U.S. headquarters in Somerset, New Jersey, eliminating 94 employees there.

Insys spending $24M on manufacturing expansion

Insys Therapeutics is scrambling to right itself after being knocked akilter by an indictment claiming its former CEO and a group of other ex-top execs bribed doctors to prescribe its Subsys painkiller. But the legal turmoil has not stopped the drugmaker from adding capacity to a Texas manufacturing site. Insys is completing a 30,000 square-foot expansion at its manufacturing site in Round Rock, Texas. The company is investing $24 million to outfit the operation and add an undefined number of jobs. In 2013, the Chandler, Arizona-based company received financial incentives from Round Rock for its $10.5 million expansion into a larger manufacturing facility in the Texas town.

Roche’s much-anticipated MS game-changer, Ocrevus, nabs its FDA green light

The new med Roche has been anticipating—and the multiple sclerosis market shake-up drugmakers have been dreading—is here. Regulators approved the Swiss drugmaker’s Ocrevus to treat two forms of the disease—relapsing remitting MS and the harder-to-treat primary progressive form—in adult patients. The thumbs-up follows a three-month delay, when the agency asked Roche for additional data on the Ocrevus manufacturing process. Now, the wait is over for Roche, which stands to win big with the blockbuster wannabe. It’s pricing the med at $65,000 per year, marking a 25% discount to Merck KGaA rival Rebif, a drug it topped in clinical trials, and a 20% discount, on average, to other MS therapies, Mizuho analyst Salim Syed wrote in a note to clients.

Greece’s corruption prosecutor quits, citing pressure over Novartis bribery probe

Novartis is embroiled in a soap opera in Greece, complete with bribery allegations and a suicide threat. Now the plot is thickening. The country’s chief corruption prosecutor, Eleni Raikou, has resigned—and she’s blaming the Swiss pharma giant’s legal issues for her decision. Raikou stepped down over the weekend, sending a letter to Greece’s Supreme Court claiming she was targeted by “unofficial power centres” over her investigation of Novartis, which started in early January. Her resignation followed a less-than-flattering article in a weekly newspaper, according to anonymous sources quoted by the wire service. In her resignation letter, she griped about a lack of “institutional protection”. Greek authorities raided Novartis’ offices in that country after one of the company’s local managers reportedly made a suicide threat on New Year’s Day at a hotel. The executive was one of the employees the authorities were interviewing, according to multiple media reports at the time.

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AstraZeneca slapped with second Complete Response Letter

Having a potential blockbuster sidelined because of manufacturing issues is bad enough, but AstraZeneca has now had that experience twice—both times receiving a complete response letter from the FDA. For a second time, AstraZeneca has received a complete response letter tied to the manufacturing of the hyperkalemia treatment, a potential blockbuster treatment that was the target of AstraZeneca’s $2.7 billion buyout of ZS Pharma in 2015. Since getting its first CRL for the drug in May 2016, AstraZeneca has been joined by a number of other drug makers that have had drug launches sidelined by manufacturing problems. Among those are Sanofi and Regeneron, which in October were issued a CRL for sarilumab, a candidate for the treatment of rheumatoid arthritis that has also been predicted to hit blockbuster numbers. The CRL was issued because of a long list of deficiencies at a Sanofi fill-finish plant in Le Trait, France.

Patheon says buyout of Roche API plant gives it border tax protection

Jim Mullen, CEO of CDMO Patheon, said the company and its clients are wondering what the Trump administration’s tax proposals will mean for them but if a border tax were to be imposed, its $1 million pickup of a former Roche API plant in the U.S. puts it good shape to face it. The tax discussion came after the contractor reported first-quarter 2017 earnings in which revenue was up 13% to $457 million and EPS on continuing operations was $0.19 a share. The company also guided lower for 2017, saying that some expected contracts had shifted and revenue from them would be realized in 2018. With the buyout last quarter of a Roche API plant in Florence, South Carolina, the company now has API sites there and in Greenville, North Carolina, and development activities in South Carolina and Europe, creating a 50-50 split between the two markets.

Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack

The last time Sanofi and Regeneron launched a drug together, Amgen sued for patent infringement. Now, with an FDA decision on their key drug Dupixent due next week, the development partners are making a pre-emptive strike in patent court. Sanofi and Regeneron sued Amgen on Monday, seeking a declaration that Dupixent, also known as dupilumab, does not infringe on a particular Amgen patent. The companies say they don’t believe Dupixent steps on Amgen’s intellectual property but want a court back that up. The lawsuit, filed in U.S. District Court in Boston, asks a judge to determine that the two companies don’t infringe on Amgen’s ‘487 patent, which cites IL-4 and IL-13 antibodies. Dupixent is a drug targeted at IL-4 and IL-13, two immune system pathways implicated in allergic diseases.

Cerulean Pharma and Daré Bioscience enter into stock purchase agreement

Cerulean Pharma Inc. and Daré Bioscience, Inc., a privately-held, clinical-stage pharmaceutical company advancing products for women’s reproductive health, announced that the two companies, together with the equity holders of Daré Bioscience, have entered into a definitive stock purchase agreement under which the equity holders of Daré Bioscience will become the majority owners of Cerulean. The transaction and the Cerulean asset sales would result in a NASDAQ-listed company with a focus on the development and commercialization of products for women’s reproductive health. Daré Bioscience’s product candidate, Ovaprene®, is a clinical stage, non-hormonal contraceptive ring for monthly use that potentially addresses a significant unmet need. Contraception is a $16 billion global market. However, since the approval of the birth control pill by the FDA in 1960, most innovation has focused on hormones.

Eli Lilly says it’s cutting an average of 50% off list prices—and its price hikes don’t work

Heightened pressure from pharmacy benefit managers and increased competition among drugmakers are taking a big bite out of Eli Lilly’s list-price hikes—an 11-percentage-point bite, on average, the company said in a new report. After raising list prices an average of 14% in 2016, and wheeling and dealing with payers, Eli Lilly netted an overall price increase of 2.4%, the company said in a new report. That’s a major comedown from 2015, when a 16.3% average increase yielded a net rise of 9.4%. Lilly joined pharma peers Johnson & Johnson and Merck in unveiling its high-level pricing data, as part of a summary of its annual report. On average, the company says discounts have grown to 50% over the last 5 years, up from 28% in 2012.

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GSK consolidates DT and TT vaccine production in Hungary plant, adding 100 jobs

With GlaxoSmithKline’s vaccines sales expanding, it figures it needs expanded production as well and some of that will happen at a 10-year-old plant in Hungary as well as Germany. GlaxoSmithKline said on Monday that it would invest £40 million (about $61.5 million) to expand its Gödöllö facility in Hungary and add about 100 jobs. The outlay is for the transfer of production of diphtheria toxoid (DT) and tetanus toxoid (TT) from GSK’s Marburg production site in Germany to its Gödöllö facility in Hungary. Work on the project is expected to begin in August with manufacturing anticipated in 2023, assuming regulatory approvals. It includes expanding production and adding a new media preparation building at the site. She said Marburg will continue production of GSK’s Infanrix and Synflorix vaccines until successful production can be established in Gödöllö to ensure a constant supply.

AZ gears up for FDA filing as PARP inhibitor Lynparza wins big in ovarian cancer trial

AstraZeneca’s Lynparza honed its edge in ovarian cancer and just in time to help preserve its lead in the marketplace. In detailed results from a test of the drug in patients who’d relapsed after platinum chemo, the first-in-class PARP inhibitor held off cancer recurrence by more than two years, compared with placebo, and delivered a statistically significant improvement in the risk of tumor progression or death. Those numbers compare favorably with Tesaro’s much-ballyhooed competitor niraparib, which delivered a 15.5-month survival advantage in its own maintenance-therapy trial presented last fall. Tesaro’s shares were down by more than 11% on the news. AstraZeneca is also testing Lynparza in other cancers, including breast cancer, where it put up solid data last month.

Novartis comes up with flex pricing scheme for newly approved Kisqali

Kisqali, a first-line treatment for HR-positive, HER2-negative breast cancer, and a rival to Pfizer’s Ibrance, will be released under a flexible pricing structure, according to the company sources after it got FDA approval. A 28-day supply of the 600-mg dose will cost $10,950, while the same supply of the 400-mg dose will go for $8,760 and the 200-mg dose will run at $4,380. While Kisqali may beat Ibrance on price, though, when it comes to safety and convenience, Pfizer’s blockbuster may have the newcomer beat. Regulators recommend patients receive ECG monitoring before starting up treatment with the Novartis med and repeat it at day 14 of the first cycle and the beginning of the second cycle.

Concordia reports $1.3B loss after taking $1.1B write-off on pressured generics

Like its Canadian peer and model, Valeant, 2016 was an ugly year for Concordia International. The Ontario-based drugmaker today reported a $1.3 billion loss—$25.76 per share—on $816 million in revenue after taking a $1.1 billion impairment charge, mostly on products that are no longer paying off so well. Concordia reported its fourth-quarter revenue of $170.4 million was down 13% in the U.S and off 8.1% overall. New CEO Allan Oberman said headwinds—which includes inquiries in the U.S. and the U.K.—“have necessitated a reassessment of our business model” for Concordia, a model that oft been said to mimic that of Valeant Pharmaceuticals because of its price hikes, rampant M&A and large debt load. He then laid out a five-point plan he said would get the drugmaker back on track.

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Clinigen and Eisai partner to offer Halaven for metastatic breast cancer in South Africa

Eisai has partnered with Clinigen Group to distribute Halaven (eribulin) in South Africa for the treatment of women with metastatic breast cancer. Discovered and developed by Eisai, Eribulin is a synthetic variant of microtubule dynamics inhibitor halichondrin B, designed to inhibit the growth phase of microtubule dynamics to prevent cell division. Eribulin is currently indicated in the European Union (EU) for the treatment of adults with locally advanced or metastatic breast cancer and for adult patients with unresectable liposarcoma.

Sanofi, Lonza enter into Joint Venture to produce monoclonal antibodies

Sanofi and Lonza have entered into a strategic partnership to build a Joint Venture whose main asset will be a facility for monoclonal antibody development and production in Lonza’s Visp site, Switzerland.  The JV will have an initial capital of CHF 290m, to which the two companies will contribute equally. Construction will begin as early as 2017, and the plant is expected to be operational by 2020. Lonza has previously built and licensed three similar facilities in the US and Singapore.

Fidia to acquire the Italian Group Sooft

SOOFT, specializing in ophthalmic products, sold 80% of the company to Fidia Farmaceutici. Fidia CEO and chairman, has reportedly announced the transaction, without providing its financial details. Sooft generated approximately €60m in revenue in 2016. Following the acquisition, Fidia can now add to its portfolio the brands Sooft, Bioos, Glaucoom, OftaH.T. and Neoox, which will allow the Abano-headquartered group to yield a revenue of €300m in 2017.

Johnson & Johnson completes acquisition of Abbott Medical Optics

Johnson & Johnson has completed the acquisition of Abbott Medical Optics (AMO), a wholly-owned subsidiary of Abbott. The all-cash $4.325 billion acquisition was originally announced Sept. 16, 2016, and includes ophthalmic products in three areas of patient care: cataract surgery, laser refractive surgery and consumer eye health. These product lines will now join with the world-leading ACUVUE® Brand Contact Lenses business, and the combined organization will operate under the brand name Johnson & Johnson Vision (J&J Vision)

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PMV Pharma Raises $74M, Aiming to Hit Cancer’s Hard Target- P53

PMV Pharmaceuticals is the latest startup to load up with cash in an attempt to home in on one of the toughest targets in cancer biology: the tumor suppressor protein known as p53. The company raised a $74 million Series B round from Topspin Biotech Fund, Euclidian Capital, InterWest Partners, OrbiMed Advisors, and Osage University Partners. PMV raised a $30 million Series A in 2014. The new cash will help PMV push into human clinical studies, though in its statement the startup didn’t say when those studies might begin. Like many of its peers, PMV wants to restore the function of mutated p53 with a drug, though it didn’t disclose exactly what its approach will be.

Argos Shares Plummet following Reports of Failed Results for Kidney Cancer Therapy

An Argos Therapeutics therapy that uses the immune system to fight kidney cancer has hit a wall after an analysis of the latest clinical trial data found that the experimental treatment was unlikely to work. Following the planned interim analysis of Argos’s Phase 3 clinical trial, the independent data monitoring committee recommended stopping the study for futility, the company announced this morning. Shares in Durham, NC-based Argos plummeted more than 62 percent to $1.65 on the news. Argos said that it is analyzing the preliminary data from the clinical trial and it plans to discuss that information with the FDA. In the meantime, Argos said that it plans to leave the clinical trial open.

Cidara Antifungal Flunks in Phase 2 Clinical Trial, Shares Sink

Cidara Therapeutics is halting work on an experimental topical antifungal drug designed to treat vaginal yeast infections after the compound wasn’t better than the current standard of care in a Phase 2 clinical trial. Investors frowned on the news, sending the company’s shares down more than 38 percent to $7.24 on 21st morning. Cidara is turning its attention to CD101 IV, which is in a Phase 2 trial for the fungal infection candidemia. Results for that clinical trial are expected in the fourth quarter. Cidara will also continue working on CD201, a potential treatment for infections caused by drug-resistant Gram-negative bacteria.

Cashing in On Duchenne Approval, Sarepta Sells Voucher to Gilead for $125M

Sarepta Therapeutics didn’t just get its first drug to market when the FDA approved the Duchenne muscular dystrophy drug eteplirsen (Exondys 51) last year—it got a potentially lucrative voucher from the FDA too. Sarepta sold the priority review voucher to Gilead Sciences in a deal worth $125 million. Sarepta will use the cash to help develop next-gen drugs for Duchenne. Priority review vouchers are awarded to companies that bring treatments to market for neglected tropical diseases and rare pediatric ailments, enabling a swifter review from the FDA, and potentially adding millions in revenue for a company, or giving a drugmaker a leg up over a competitor with a rival therapy.

Novartis and NHS Ayrshire & Arran launch new eye care facility in Scotland

Novartis Pharmaceuticals UK and NHS Ayrshire & Arran have announced the launch of a new facility designed specifically for people suffering from some of the most common forms of avoidable sight loss. The facility is set to support the delivery of a one-stop clinic for patients and is expected to transform the patients’ eye service by building an extension on to the existing Ophthalmology Outpatient Department.

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Mead Johnson Acquired By Reckitt Benckiser for $16.6 Billion

Mead Johnson Nutrition Company (MJN), the manufacturer of infant formula and nutritional supplements, has agreed to be acquired by Britain’s Reckitt Benckiser Group plc in a deal that values the former’s equity at $16.6 billion. Mead Johnson shareholders will receive $90 in cash for each share. Adding the company’s net debt brings the total value of the transaction to $17.9 billion and the deal is expected to close by the end of Q3 2017. RB expects the integration to deliver cost savings of 200 million pounds per annum by the end of the third full year, and it says the acquisition will be accretive to adjusted diluted EPS in the first full year following completion and double‐digit accretive by year 3.

LabCorp explores acquisition of clinical trials firm PPD

Laboratory Corporation of America Holdings (LabCorp) is in talks to acquire contract researcher Pharmaceutical Product Development LLC (PPD) for more than $8 billion, including debt, people familiar with the matter said on Friday. Such a deal would be LabCorp’s largest acquisition ever, advancing its strategy of combining laboratory testing services under one corporate umbrella following its acquisition of contract research organization Covance Inc in 2015 for $5.7 billion.

Ferring collaborates with Foresee to use the latter’s controlled-release tech

Ferring Pharmaceuticals has struck a deal with Foresee Pharmaceuticals. The agreement will see Ferring fund development of a long-duration peptide drug based on Foresee’s delivery technology and potentially pick up the resulting asset if it meets expectations. Foresee has landed the deal on the strength of its stabilized injectable formulation (SIF) platform, a technology the Taiwanese drugmaker developed to enable controlled-release delivery of peptides, small molecules and proteins. Ferring penned a deal to use the technology to create a formulation of an as-yet-unidentified peptide after assessing the progress made by Foresee to date.

Johnson & Johnson Licenses its HIF portfolio to Akebia

Johnson & Johnson has outlicensed its portfolio of hypoxia-inducible factor (HIF) to Cambridge MA-based Akebia as the biotech boosts its early-stage pipeline. On top of this, Johnson & Johnson’s Innovation unit (aka JJDC) has also written in a clause for it to “take an ownership interest” in Akebia through a common stock purchase warrant for 509,611 shares. This can be used by JJDC, in whole or in part, at any point over the next five years with a payment to Akebia of up to $5 million. The first part of the deal, which sees the biotech cough up $1 million to J&J, also sees the biotech gain access to a library of HIF pathway compounds, which it says in a statement has the potential to be used across “multiple therapeutic areas.”