Struggling injection device specialist Unilife said in an SEC filing that it needs an additional week to negotiate a deal with potential savior Amgen, which would involve the big biotech purchasing up to 19.9% of the company's stock in return for a much-needed cash infusion. If the grand alliance pans out, Amgen would also gain the preferred right of access to new drug delivery platforms and enter into a manufacturing arrangement with Unilife.
Struggling injection device specialist Unilife said in an SEC filing that it needs an additional week to negotiate a deal with potential savior Amgen, which would involve the big biotech purchasing up to 19.9% of the company's stock in return for a much-needed cash infusion. If the grand alliance pans out, Amgen would also gain preferred right of access to new delivery platforms and enter a manufacturing arrangement with Unilife.
Amgen's Repatha is in a market brawl with Sanofi and Regeneron's Praluent as the competitors rush to sew up as many OKs around the world as possible for the new-gen cholesterol fighters following their FDA approval last year within weeks of one another. Now Amgen has pulled ahead in England after the country's drug pricing watchdog has both changed course to cover Repatha for some patients, while dealing its competitors a blow with a rejection for Praluent.
Norway became the first overseas country to approve the Enbrel biosimilar made by Samsung Bioepis for sale, coming two weeks after the drug, Benepali, was approved by the European Commission.
Amgen said that the approval for Repatha (evolocumab) in Japan filed by Amgen Astellas Biopharma K.K., a joint venture with Tokyo-based Astellas Pharma, could be launched within months pending reimbursement details.
Genentech has moved to the head of a small group of players in the anti-inflammatory arena, bagging rights to an antibody that scrambles the connection between IL-33 and the ST2 receptor--two biomarkers pegged for their role in a variety of lung ailments--from Amgen.
Amgen had a steady stream of significant new drug approvals in 2015, like the FDA nod for its Repatha which is in a new class of cholesterol fighters that are expected to generate significant sales. But Repatha and several others are too early in their launch to register separately on the sales line, and it was growth in sales of Amgen's tried-and-true drugs that allowed the biotech to breeze by analyst expectations.
On Monday, Amgen said the FDA had accepted its application for its biosimilar of AbbVie's Humira, so-called ABP 501--but earlier this month, the U.S. Patent and Trademark Office shut down its challenge to Humira's patents.
Amgen's take on AbbVie's top-selling inflammation treatment is in line for FDA approval this year, but a patent fight between the two companies could keep it off the market into the next decade.
One of the hottest races for market share in pharma these days is between Amgen's cholesterol-fighter Repatha and Praluent, from Sanofi and Regeneron. They're apparently neck and neck with payers, and their script numbers aren't much different either, at least so far.