The Business Cocktail

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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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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ALCMI, ALCF and Scancell partner to evaluate SCIB2 cancer vaccine for NSCLC

The Addario Lung Cancer Medical Institute (ALCMI) and the Bonnie J. Addario Lung Cancer Foundation (ALCF) have collaborated with UK-based Scancell to assess SCIB2 cancer vaccine to treat patients with non-small-cell lung cancer (NSCLC). SCIB2 is Scancell’s second ImmunoBody cancer vaccine platform currently under development. It stimulates the immune system to potentially treat and prevent cancer. Scancell has successfully completed a Phase I / II clinical trial with SCIB1 cancer vaccine by using it on patients suffering from melanoma. Along with having the ability to complement existing treatments, SCIB2 can also work in cases where current treatments either do not work or are not available.

Sun looks to unload Ohm Labs New Jersey plants in manufacturing consolidation

The Indian company is reportedly looking to sell New Jersey plants as part of a manufacturing consolidation. The facilities have been on the market for a couple of months and are expected to fetch about $100 million. Sun Pharma got the solid-dose, prescription and OTC manufacturing facilities in its 2015 buyout of Ranbaxy Laboratories, and is slimming down its manufacturing operations since the buyout, last year selling plants in Philadelphia, Pennsylvania, and Aurora, Illinois, to CDMO Frontida BioPharm. Before that, it struck a deal to sell a formulation plant in Bryan, Ohio, to Nostrum Laboratories, a Kansas City, MO-based generics maker, and announced the closure of a plant in Tipperary, Ireland.

Takeda and Ovid join forces to co-develop Drug for Rare Pediatric Epilepsies

In January 2017, Takeda and Ovid Therapeutics announced an agreement to co-develop a drug for rare pediatric epilepsies. Takeda’s compound, TAK-935, is at the heart of this agreement, with its continued development and commercialization in the US, Europe, Canada, and Israel being conducted by Ovid. Takeda will be developing the drug in Japan and other Asian markets. This unusual agreement also allows the companies to share the development and commercialization costs 50/50, and in the event of a successful launch to share profits equally as well.

Guardant and MD Anderson collaborate for liquid biopsy deal

Guardant Health and the University of Texas MD Anderson Cancer Center have struck a multiyear deal to push comprehensive liquid biopsy into the standard of care in cancer treatment. The commercial, research and development agreement will see Guardant helping MD Anderson build multiple liquid biopsy centers on site, according to a statement. The company launched its Guardant360 test in 2014 and says it is the most validated and sensitive liquid biopsy on the market.

Glooko and Ascensia integrate their offerings to boost diabetes management

In its second partnership announced this month, Glooko is teaming with Ascensia Diabetes Care to connect the latter’s blood glucose monitoring systems to its diabetes data management platform. Under the partnership, the pair will integrate Ascensia’s Contour Next One and Contour Plus One systems into Glooko’s platform. The goal is to improve diabetes data management and analytics for patients and physicians. Earlier this month, Glooko and Novo Nordisk joined forces to develop “digital health solutions” for diabetes management.

 

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Payers block Kaléo’s expensive EpiPen challenger

Kaléo reintroduced its Auvi-Q last week at a list price of $4,500 for a two-pack in an effort to capture some market share from Mylan’s EpiPen, which is listed at about $600 for a two-pack. Auvi-Q is set to launch next month. Under Kaléo’s pricing strategy, Auvi-Q will cost most patients $0 out-of-pocket. If an insurer refuses to cover the med, the company will step in and pay for that access, execs said last week. Uninsured patients can purchase the drug at a cash price of $360 for a two-pack. Instead, the strategy shifts the costs to insurers and pharmacy benefit managers. At a list price multiples higher than its competition, Kaléo Pharma’s revived Auvi-Q has hit resistance from some of the nation’s top pharmacy benefit managers and insurers. Cigna has said no to the idea, while Humana is not talking to the company and Aetna is restricting its product for now.

FTC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

According to the FTC complaint, Lidoderm was an important product for Endo back in 2011. That year, the company made $825 million in sales off the lidocaine patch, or 30% of its annual sales haul, meaning generic competition would pose “significant financial risks” to the company. Endo paid Watson at least $250 million to delay that competition, according to the feds. Through an “administrative complaint,” authorities are also going after Impax Laboratories, which they say received $112 million back in 2010 to delay a generic competitor to Endo’s Opana ER. Endo International has pledged to swear off pay-for-delay agreements. But even as the government moves to wrap up its case against Endo, authorities continue to pursue claims against Watson and Allergan.

Amgen hikes prices by single digits, with Enbrel matching AbbVie’s Humira boost

Amgen raised the price of its top-selling med, Enbrel, an 8.4% hike that followed a larger one just six months ago. It also came on the heels of an identical price hike for one of Enbrel’s key competitors, AbbVie’s Humira. Amgen executives say payer discounts will eat up most if not all of its latest hikes. The move follows a 28% increase for the anti-TNF blockbuster in 2015 and another boost of 9.9% in July 2016. During Amgen’s third-quarter 2016 conference call, commercial operations head Anthony Hooper said the company expects “relatively little benefit” on Amgen price changes in 2017 due to competitive payer negotiations.

Baxter paying $18M to settle federal case over sterile plant failings

Ignoring issues in a sterile manufacturing plant can lead to big problems, like FDA warning letters, which Baxter International received for a plant in North Carolina after mold was found in HEPA filters. But in rare cases, it can lead to even more severe penalties, like the $18 million-plus Baxter will pay to resolve a federal criminal case, as well as a civil matter brought by a whistleblower over the mold concerns.  Baxter will pay another $2.158 million to resolve a civil whistleblower case brought by Baxter employee Christopher Wall who had reported to the mold problem to plant management. Wall’s case alleged his concerns were overlooked and the plant continued to manufacture and sell product from the facility. Wall gets $431,535.99 as his share of the settlement.