Biopharmaceutical NewsWeek # 8

Business

September 16, 2014 

AstraZeneca and Eli Lilly partner up on Alzheimer’s drug

Under the terms of the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. The companies will share all future costs and revenues post-launch. The compound in question, AZD3293, an oral beta secretase cleaving enzyme (BACE) is expected to prevent the formation of amyloid plaque and slow the progression of the disease.

September 17, 2014 

Merck signs psoriasis drug licensing pact with Sun Pharma 

Merck & Co. granted Sun Pharmaceutical Industries global rights to manufacture and market its experimental drug tildrakizumab, which is in late-stage trials for psoriasis. In exchange, Sun, an Indian drugmaker, agreed to pay Merck $80 million upfront plus undisclosed milestone payments and royalties. Tildrakizumab, which is in Phase III for psoriasis, has shown efficacy in blocking inflammation by blocking IL-23. Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s disease.

Merck Serono signs deals with Sutro

Merck Serono and Sutro Biopharma, a US base biotechnology company have agreed to establish a collaboration and license agreement to develop antibody drug conjugates. The companies will work together to discover and develop multiple ADCs – antibodies linked to cytotoxic drugs for more targeted delivery – using Sutro’s cell-free protein synthesis platforms .The US biotech will be responsible for delivering ADCs for Phase I clinical trials, while Merck Serono, will have the responsibility for clinical development and commercialisation of any resulting products. Merck Serono will make an upfront payment to Sutro and will fund certain R&D activities, while its partner will receive payments on completion of certain research, development and regulatory milestones of up to around 230 million Euros as well as royalties on product sales in return. 

Sanofi discloses a partnership with MyoKardia

Sanofi has established a partnership with US MyoKardia to develop therapies for patients with genetic heart diseases. This collaboration is focused around the discovery of “first-of-its-kind targeted therapeutics” for cardiomyopathies, the most common forms of heart muscle disease. Cashwise, the collaboration is worth $200 million in equity investments, milestone payments and R&D services through 2018. Some $45 million has already been paid through an upfront fee and an undisclosed stake Sanofi has taken in privately-held MyoKardia. The pact has come out of the Sunrise initiative, a strategic partnership model for investing in early-stage opportunities.

September 18, 2014

OSE Pharma, a French cancer immunotherapy specialist prepares its IPO

French cancer immunotherapy specialist OSE Pharma has registered with market regulator AMF for an initial public offering (IPO) aimed at financing late-stage trials of its Texopi drug for the most common form of lung cancer. Texopi has already been tested in a Phase II study in patients with non-small cell lung cancer and is set to undergo Phase III trials in the second half of next year.

Bayer announces a focus on life sciences business

Bayer is to abandon its traditional three-pillar business model and focus on healthcare and crop science and float its material sciences division on the stock market as a separate company. The spin-off will help Bayer “position itself as a world-leading company in the field of human, animal and plant health”. Bayer has seen its healthcare operations blossom oand earlier this year stated that the anticoagulant Xarelto (rivaroxaban), the eye drug Eylea (aflibercept) and the new cancer treatments Xofigo (radium 223) and Stivarga (regorafenib), plus the pulmonary hypertension treatment Adempas (riociguat), will have peak sales of at least 7.5 billion euros per year.

Approval of drugs

September 16, 2014

FDA approves AstraZeneca's constipation drug Movantik

The US FDA approved an oral therapy to treat opioid-induced constipation developed by Nektar Therapeutics and AstraZeneca Plc. The drug, known generically as naloxegol, an oral once-a-day treatment licensed from Nektar Therapeutics, belongs to a class of drugs called “peripherally-acting mu-opioid receptor antagonists”, which are used to decrease the constipating effects of opioids. This class of drugs had been linked with cardiovascular risk in the past. The drug will be sold under the trade name Movantik, and is indicated for patients on opioids for pain unrelated to cancer.

September 19, 2014

FDA approves Lilly's diabetes drug Trulicity

The US FDA has approved dulaglutide, Eli Lilly’s once-weekly glucagon-like peptide-1 receptor agonist for type 2 diabetes, to be marketed as Trulicity. The FDA is nevertheless requiring post-marketing studies for Trulicity, including a trial in paediatric patients and one comparing the Lilly drug with Sanofi (insulin glargine) on glycaemic control and moderate or severe renal impairment. The agency is also asking for a cardiovascular outcomes trial. Trulicity will compete against other GLP-1 receptor agonists, including Novo Nordisk’s Victoza (liraglutide) and AstraZeneca’s Byetta (exenatide) and its long-acting version Bydureon.

Europe approves Novo Nordisk diabetes combination treatment Xultophy

The European Commission has granted marketing authorisation for Novo Nordisk’s new combination treatment Xultophy. Xultophy is a once-daily single injection combination of Tresiba (insulin degludec) and Novo’s blockbuster Victoza (liraglutide). It is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering drugs when these alone or combined with basal insulin do not provide adequate glycaemic control. Novo plans to launch the product in the first semester 2015.

Drugs at clinical stage

September 15, 2014 

Merck osteoporosis drug Odanacatib passes trial

Merck & Co said it will seek U.S. approval next year for its long-delayed experimental osteoporosis drug, odanacatib, after it proved effective in a late-stage trial but was associated with rare thigh-bone fractures seen with standard treatments. The once-weekly pill significantly reduced risk of fractures of the hip and spine, and of non-vertebral fractures, compared with placebo. Odanacatib works by blocking cathepsin K, an enzyme involved in the body's natural process of resorbing bone.

Miscellaneous

September 17, 2014

A first case of Ebola for a French citizen

A volunteer of the Non Governmental Organisation (Médecins sans Frontières), working in Monrovia (Liberia), is the first French citizen reported to be contaminated by the Ebola virus. She was transferred back to France in a dedicated military hospital near Paris.

A massive management shake-up at Takeda

Takeda has announced a new reorganized company structure which includes a new org chart, and a fresh set of top managers, including a replacement for Anna Protopapas, the current President of Millenium. Takeda will establish five so-called regional business units consisting of Japan Pharma, Emerging Markets, United States, Europe-Canada and Japan Consumer Healthcare, along with a pair of specialty business units for oncology and vaccines. R&D will be realigned, too, to focus on four therapeutic domains: central nervous system; cardiovascular and metabolic; gastroenterology; and oncology. Cambridge-based Millennium will become the new center of Takeda's oncology efforts, with Christophe Bianchi stepping up to head the unit as Millennium's Protopapas departs.

September 19, 2014

GSK China scandal resolved with $500 million fine and suspended jail sentence

Chinese justice came swift for GSK. A top executive narrowly escaped jail sentence, the company was convicted and will have to pay a fine of nearly $500 million for bribery. This outcome leaves other drug makers to wonder what is up for them in a near future.

Author : Jean-Claude MULLER, Special Advisor,Innovation & International Relationship (I&IR)

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