[Updated, 9:30 am ET] What summer vacation? Biotech was booming on the East Coast this week. Big partnerships, clinical trial results, R&D days, and new executive hires were all announced. We’ve got those details and much more below:
—Over the past few years, Summit, NJ-based Celgene (NASDAQ: [[ticker:CELG]]) has formed early-stage partnerships with innovative biotechs such as Agios Pharmaceuticals, Epizyme (NASDAQ: [[ticker:EPZM]]), and Bluebird bio (NASDAQ: [[ticker:BLUE]]). I spoke with George Golumbeski, Celgene’s senior VP of business development, about the company’s flexible early-stage deal-making strategy, the trust Celgene has in its partners, and the evolving landscape of biotech collaboration deal structures.
—Celgene also released positive results from a late-stage clinical trial testing lenalidomide (Revlimid) as a front-line treatment for patients with multiple myeloma. Celgene won’t release the full details from the study until December, but based in the data, it plans to seek approval from regulators in the U.S. and Europe to position lenalidomide as a potential treatment for newly-diagnosed patients (the drug is currently approved to treat patients who haven’t responded to at least one prior therapy). Celgene’s shares skyrocketed to an all-time high on the news.
—Two months after abruptly leaving oncology powerhouse Millennium Pharmaceuticals, Deborah Dunsire has found a new company to sink her teeth into. Dunsire has become the president and CEO of EnVivo Pharmaceuticals, a Fidelity Biosciences-backed, Watertown, MA-based biotech startup targeting CNS disorders such as Alzheimer’s Disease and schizophrenia. While Alzheimer’s, in particular, is a field littered with past drug failures, Dunsire notes that EnVivo’s lead drug, EVP-6124, targets Alzheimer’s symptoms and isn’t trying to cure the disease.
—[Updated with new item] Cambridge, MA-based Agios Pharmaceuticals set the range for its IPO on Friday, according to an amended Form S-1 filed with the Securities and Exchange Commission. The cancer metabolism specialist plans to sell 5 million shares at between $14 and $16 apiece, which would give it $75 million in proceeds at the middle of its range. Celgene, which both has a broad partnership with Agios and is one of its largest stockholders, has also agreed to buy $12.75 million worth of additional shares at the IPO price through a private placement concurrent with the offering. Agios will trade on the Nasdaq under the ticker symbol ‘AGIO.’
—Watertown-based Forma Therapeutics signed a partnership with Cancer Research Technology Ltd., the commercial arm of Cancer Research UK, giving a hand-picked team of researchers access to compounds developed by Forma with the goal of discovering drugs that target a class of enzymes implicated in the field of protein homeostasis. The deal is the first collaboration of a broad initiative that Forma refers to as its “Asset Discovery and Development Company” or “ADDco” plan, which the company will use to create a group of independent subsidiaries holding intellectual property rights to one drug, or even several drugs.
—The Aveo Oncology (NASDAQ: [[ticker:AVEO]]) saga continued Thursday as the Cambridge-based biotech revealed that it has been subpoenaed by the Securities and Exchange Commission, the latest domino to fall since an FDA advisory panel blasted the company and its cancer drug, tivozanib, on May 2.
—Monmouth Junction, NJ-based Tyrx won FDA approval of the second iteration of its AigisRX Antibacterial Envelope, a drug-device combination used to prevent infections in patients getting an implantable electronic cardiac device such as a pacemaker or defibrillator. The new version of the device dissolves completely, whereas the original system only partially does and leaves a substrate that remains with a pacemaker over the long-term. Tyrx CEO Bob White told me the new approval could lead the company to be cash-flow positive by the end of the year.
—Cambridge-based Alnylam Pharmaceuticals’ (NASDAQ: [[ticker:ALNY]]) shares surged on Thursday—just before its R&D day—as the company released data from an early-stage clinical trial suggesting that it might be able to deliver its RNA drugs to patients with an injection just under the skin. If it can prove the method works, Alnylam wants to use subcutaneous injections, rather than intravenous infusions, for all of its drugs.
—Cambridge-based Merrimack Pharmaceuticals (NASDAQ: [[ticker:MACK]]) announced plans to raise $125 million by offering investors $50 million in common stock and $75 million in convertible senior notes. Merrimack will use the cash to complete the development and fund the potential commercialization of its pancreatic cancer drug candidate MM-398. Merrimack’s stock plummeted close to 20 percent on news of the dilution.
—Investors also bristled at Bedminster, NJ-based Amarin’s (NASDAQ: [[ticker:AMRN]]) move to raise cash by selling 21.7 million shares at a public offering. The fish-oil pill developer’s stock tumbled about 11 percent over the course of the week.
—The Therapeutic Goods Administration cleared Cambridge-based Vertex Pharmaceuticals (NASDAQ: [[ticker:VRTX]]) to begin selling its cystic fibrosis drug, ivacaftor (Kalydeco), in Australia.
—Ardsley, NY-based Acorda Therapeutics (NASDAQ: [[ticker:ACOR]]) completed a previously announced buyout of certain rights to struggling NeurogesX’s post-shingles nerve pain treatment made from the active ingredient in chili peppers, capsaicin (Qutenza), as well as a late-stage product for diabetic neuropathy known as NP-1998. Acorda paid $8 million for partial rights to the capsaicin-based treatment, and agreed to pay up to $5 million in milestones for NP-1998. The deal was first announced in April.
