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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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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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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Sun Pharma & ICGEB announce exclusive collaboration to develop novel dengue vaccine

International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma Ltd. announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. ICGEB has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate.

Boehringer Ingelheim and Lupin Sign agreement for Diabetes Drug

Drug firms Boehringer Ingelheim and Lupin have entered into a partnership to co-market Empagliflozin used for treatment of type 2 diabetes in India. Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin’s specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through their existing sales force and network

Daiichi Sankyo Announces New Strategic Immuno-Oncology Research Collaboration with AgonOx

Daiichi Sankyo announced that it has entered into a strategic collaboration with AgonOx, Inc., a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target. Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide

Catalent Pharma Solutions partners with Samsung Bioepis Co. for Commercial Biosimilar supply

Catalent Pharma Solutions announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel® (etanercept), on behalf of the Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium. SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali.

Celltrion Healthcare and Teva enters into exclusive business collaboration agreement for Truxima™ and Herzuma™ in the U.S. and Canada

Celltrion’s commercial partner for its second and third biosimilars for the North America market has been determined. Celltrion announced that it has selected Teva Pharmaceuticals, as its exclusive commercial partner for Truxima and Herzuma in the US and Canada. Celltrion has applied for marketing authorization from the EMA last October. Mabthera (also known as Rituxan), the reference product to Truxima, was developed by Biogen and marketed by Roche.  Herzuma is a biosimilar to Herceptin, a breast cancer treatment antibody biologic drug developed by Genentech and marketed by Roche.