Mylan goes on with its hostile bid over Perrigo in a deal valued at $27 billion. Under the unveiled proposal, Perrigo stockholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share, equating to about $187 a share overall. According to Perrigo’s management the offer remains under Mylan’s original bid valued at $205 per share at the time.
AstraZeneca licenses drug delivery dendrimer nanotechnology from Starpharma (Melbourne, Australia) for the development of an undisclosed oncology programme. The DEP® Platforms uses proprietary dendrimers, with the aim of enhancing the dosing and efficacy characteristics of drugs.Starpharma’s lead internal development candidate is DEP®docetaxel. Under the terms of the agreement AstraZeneca will pay Starpharma $2 million for the use of the platform and $124 million for potential development, launch and sales milestones, as well as tiered royalties for the first DEP® AstraZeneca product.
…. and acquires Wellstat Therapeutics’ (Gaithesburgh, MD, USA) Rare Pediatric Disease Priority Review Voucher received from US FDA for Xuriden for undisclosed financial terms (vide infra).
Biogen licenses Mitsubishi-Tanabe’s MT-1303, an investigational drug with several potential autoimmune indications in a deal worth more than $500 million. MT-1303 is an orally active drug which targets the sphingosine-1 phosphatase (SP1) receptor to be evaluated in ulcerative colitis as well as in Crohn’s disease. Under the terms of the deal, Biogen will receive worldwide rights to MT-1303, excluding Asia, in return for an upfront payment of $60 million and up to $484 million in additional milestone payments.
Purdue Pharma (Stamford, CN, USA) acquires, VM-902A, a chronic pain programme from VM Pharma (Fremont, CA, USA) for up to $213 million. VM-902A is an orally bioavailable peripherally acting allosteric inhibitor of protein kinase TrkA, the high affinity receptor of nerve growth factor (NGF). Purdue Pharma will pay VM Pharma an unspecified upfront payment and contingent product related milestones as well as royalties on sales.
Novo Nordisk collaborates with the Langer Laboratory at the Massachusetts Institute of Technology (MIT) to develop oral alternatives to parenteral or injection-based delivery of peptides. The initial term of the collaboration is three years with the option to extend for up to three additional years.
Cellectis (Paris, France) enters into a three-year collaboration with MD Anderson Cancer Center (Houston, TX, USA) to bring new cellular immunotherapies to patients suffering from haematological cancers. The strategic alliance is aimed at developing new cancer immunotherapies based on Cellectis' allogeneic chimeric antigen receptor (CAR) platform. "This alliance could potentially drive to 5 clinical developments within a time horizon of 3 years," says Mathieu Simon, the COO of Cellectis.
Evotec (Hamburg, Germany) enters into a four year research collaboration with Pfizer to explore novel mechanisms to target anti-fibrotics and multi-organ fibrosis. Specific financial terms were not disclosed but include an upfront payment to Evotec and development and sales-based milestones.
Takeda and Gencia (Charlottesvile, VA, USA) have entered a partnership to develop drugs acting as mitochondrial agonists of the glucocorticoid receptor for the treatment of cancer and inflammatory disease. These drugs are meant to be chemically and functionally different from corticosteroids but produce the same therapeutic benefit without their negative side effects. Gencia could receive up to $500 million in milestone payments plus royalties on sales.
Approval of drugs, vaccines, diagnostics and devices
US FDA approves Wellstat’s Therapeutic’s Xuriden for the treatment of ultra-rare metabolic hereditary disease named orotic aciduria. The sufferers of the life-threatening disorder cannot synthesize adequate amounts of uridine which leads to excessive excretion of orotic acid. Xuriden is an orally active analog of pyrimidine which delivers four to seven times more uridine than oral administration of uridine itself. The FDA also granted Wellstat a rare Pediatric Disease Priority Review Voucher which can be sold or transferred an unlimited number of times. Wellstat will sell its voucher to AstraZeneca according to a September 2014 agreement.
European Commission approves Santhera Pharmaceutical’s (Liestal, Switzerland) Raxone for the treatment of patients with Leber’s Hereditary Optic Neuropathy, an inherited mitochondrial disease which often leads to rapid, profound and permanent blindness. Raxone (idebenone), a synthetic analog of coenzyme Q10, is the first treatment approved for a mitochondrial disease in Europe.
In the previous edition, we had indicated that Alexion’s Kanuma, an enzyme replacement for patients with lysosomal acid lipase deficiency, had received the EU commission approval. This is not so in the US where the drug review has been pushed back after the FDA requested more Chemistry, Manufacturing and Controls (CMC) information.
South Korea’s Ministry of Food and Drug Safety has approved Brenzys, a biosimilar version of Amgen’s Enbrel, developed and manufactured through the Joint Venture of Samsung Bioepis and Merck & Co.
Drugs at clinical stage
US FDA grants breakthrough status to a Chugai Pharmaceuticals ACE910, a bispecific antibody for the treatment of haemophilia.
GlaxoSmithKline/Theravance BREA Ellipta fails in a large survival trial in COPD patients. The study called SUMMITT, involving 16,485 patients across 43 countries was assessing the impact of Relvar/BREO Ellipta (fluticasone/vilanterol dry powder for inhalation) on cardiovascular disease in patients with chronic obstructive pulmonary disease (COPD), failed to achieve primary endpoint of statistically significance in survival benefits when compared to placebo. The failure of the study is a severe setback for GlaxoSmithKline’s respiratory division who was to have returned to growth next year based partly on SUMMITT.
Science and Technology
A new giant virus coming from the permafrost : Ten years after the discovery of the first giant virus, a franco-russian team lead by Jean-Michel Claverie (University of Aix-Marseille, France) has identified a new giant virus named “Mollivirus sibericum” containing 500 genes which was found in minute quantities in Siberian permafrost. The authors warn that “the thawing of permafrost either from global warming or industrial exploitation of circumpolar regions might not be exempt from future threats to human or animal health”.
Medical Devices and Diagnosis News
Biogen CEO George Scangos told The Wall Street Journal, he wants Biogen to conduct research that is aimed at creating new wearable and even ingestible devices that are going “to transform the way we do clinical trials. It may be a while before there's a regulatory accepted endpoint," he said, "but it will be a shorter time before they are able to provide useful information to companies like us as we conduct earlier stage clinical trials."
Issues on pricing
According to the Institute for Clinical and Economic Review (ICER) – a non-profit organization that evaluates the evidence on the value of medical tests, treatments and delivery system innovations, in other terms a cost watchdog, located in Boston (MA, USA) – Sanofi/Regeneron’s Praluent and Amgen’s Repatha offer enough benefits to justify a price range of $3,615 to $4,811 per year, a 67% discount of the list of the current pricing in the US. "Even if these drugs were used in just over 25% of eligible patients, employers, insurers, and patients would need to spend on average more than $20 billion a year for these drugs, a cost that would continue on into the future," said ICER President Steven Pearson. To get costs down to a level where doctors and payers wouldn't have to try to limit patients' access to the drugs, ICER says, the prices for these drugs should be $2,177 or less, a 85% discount over the current pricing.
The British National Health Service (NHS) has pulled funding for 17 cancer therapies from its Cancer Drugs Fund list as an attempt at controlling cancer treatment costs. Several drugs will not be covered at all in the future, among them Genentech’s Kadcyla (trastuzumab emtansine) and AbbVie’s Imbruvica (ibrutinib), others have only been delisted for certain indications. One of those is Roche’s Avastin (bevacizumab), which will no longer be covered in the treatment of breast cancer, cervical cancer and metastatic colorectal cancer. The NHS said that despite increasing the budget for the fund by 70% since August 2014, it would still not cover expenditure in 2015, resulting in an over-spend of £70m. In uncharacteristically strong language, Roche’s CEO Severin Schwan called the decision "stupid and completely arbitrary. The decision to stop funding the products shows a short-sighted focus on the drugs' prices, rather than on their overall value to the health system”, he said last Tuesday.
AstraZeneca purchases Amgen’s manufacturing facility in Boulder (CO, USA) for an undisclosed price allowing the UK company to double its US manufacturing capacity for biologics, given that half of its current development pipeline are large-molecules.
- BioPharm America 2015 on September 15-17 in Boston (USA)
- Redefining Early Stage Investments (RESI) Conference on September 16 in Boston (USA)
- 15th Annual Biotech in Europe Forum for Global Partnering & Investment on September 29-30 in Basel (Switzerland)
- Innovation Days on October 5-6 in Paris (France)
- FierceBiotech Executive Summitt on October 12 in London (UK)
- BIO Japan on October 13-16 in Yokohama (Japan)
- BIO Latin America on October 14-16 in Rio de Janeiro (Brazil)
- BIO Investor Forum on October 20-21 in San Francisco (USA)
- BIO Europe 2015 on November 2-4 in Munich (Germany)
- Biofit 2015 on December 1-2 in Strasbourg (France)
Author: Jean-Claude Muller, Special Advisor at I&IR, firstname.lastname@example.org