Bio Roundup: Feds Sue Gilead, Biogen Eyes China, CRISPR’d Kidneys & More

Xconomy National — 

During the state of the union address this year, President Trump pledged to end HIV transmission within the next decade. A key part of that plan is an HIV prevention drug made by Gilead Sciences. That drug has now become the center of a patent dispute between the Foster City, CA, drug maker and the federal government.

This week, the government filed a patent infringement suit in federal court against Gilead (NASDAQ: GILD). Though Gilead had initially won approval for its drug, Truvada, as a post-infection treatment, its approval for HIV prevention followed research and clinical testing by the Centers for Disease Control and Prevention. The government claims Gilead is infringing on its patents covering that use of Truvada, and the company owes royalties from its sales of the drug. Last month, the FDA approved Descovy, a second Gilead HIV prevention drug. The government claims its patents cover that drug, too.  But Gilead contends that government patents on both products are not valid.

There’s a lot of money at stake. Truvada costs a patient about $20,000 annually, and the drug has become a blockbuster seller for Gilead. As Truvada’s patents expire, Descovy is being positioned as its successor. But the company won’t let the patent dispute get in the way of President Trump’s HIV eradication plans. Gilead has said it will provide free Truvada for that cause.

In other news this week, two biopharma firms positioned themselves to sell more drugs in China; a pair of neuroscience companies reported clinical trial failures; and the FDA OK’d a new antibiotic. Let’s get right to rounding up the latest life sciences headlines.


—eGenesis, which is applying CRISPR gene editing to make pig organs suitable for human transplant, raised $100 million to advance its kidney program toward clinical trials.

—AstraZeneca (NYSE: AZN) announced it would open new R&D and artificial intelligence centers in China, along with a $1 billion fund to support companies pursuing biotech innovation in that country.

Intrepida Bio launched out of San Diego’s Dauntless Pharmaceuticals with $9.5 million and plans to advance a preclinical antibody developed by Italy’s Biouniversa to target pancreatic cancers and other forms of the disease.

—Shape Therapeutics, which is developing an RNA-editing gene therapy technology that it says avoids the risks associated with CRISPR-based editing, raised $35.5 million in Series A financing. The Seattle biotech aims to treat genetic diseases.

—A2 Therapeutics launched with $52 million in Series A financing, which the Vancouver, BC-based biotech will use to develop cell therapies that treat solid tumors.

—Galera Therapeutics (NASDAQ: GRTX) raised $60 million from its IPO. The Malvern, PA-based cancer drug developer priced its offering of 5 million shares at $12 apiece, which was below its targeted $14 to $16 per share range.


—Biogen (NASDAQ: BIIB) expanded its biosimilar strategy, reaching a deal to pay Samsung Bioepis $100 million for rights to two biosimilars for eye diseases. The company also gained China rights to three biosimilars for inflammation.

—Medical device giant Stryker (NYSE: SYK) agreed to pay $4 billion to acquire Wright Medical (NASDAQ: WGMI), a company that complements its trauma and extremities business and also has biological products for bone and tissue healing.

—Takeda Pharmaceutical (NYSE: TAK) reached a deal with MD Anderson Cancer Center granting it access to natural killer cell therapies. The Japanese pharma giant aims to develop cell therapies that can be administered in an outpatient setting. No financial terms were disclosed.

—In other Takeda (NYSE: TAK) news, the Japan pharma agreed to sell off another slate of its products as part of its ongoing plan to divest $10 billion in assets after acquiring Shire; the latest set, an assortment of over-the-counter and prescription drugs valued at $660 million, will go to Germany’s Stada Arzneimittel.

—Epizyme (Nasdaq: EPZM) inked a financing agreement with Royalty Pharma and its affiliate Pharmakon Advisors that could provide it with $270 million total, starting with $100 million up front in exchange for shares, to help get its investigational cancer drug to market.


—Steve Kafka, the former chief operating officer of Foundation Medicine, left his role at Third Rock Ventures to join venture capital firm Section 32.

—The Trump administration nominated Stephen Hahn, the chief medical executive at the University of Texas MD Anderson Cancer Center and the former chair of radiation oncology at the University of Pennsylvania School of Medicine, to become the next FDA commissioner.

—An experimental Halozyme Therapeutics (NASDAQ: HALO) pancreatic cancer drug failed a Phase 3 study, and the company announced it will shutter its cancer operations and focus on its drug delivery technology.

—RedHill BioPharma (NASDAQ: RDHL) won the FDA nod for Talicia, a capsule containing three approved products which together treat Helicobacter pylori bacterial infection in adults.

—Anaptys Bio (NASDAQ: ANAB) announced that etokimab, its experimental treatment for moderate-to-severe atopic dermatitis, failed to beat a placebo in a Phase 2 study. Consquently, the company will postpone the start of a separate Phase 2b study testing the drug in eosiniphilic asthma.


Arkuda Therapeutics closed $44 million in Series A financing to continue developing a drug that addresses an inherited protein deficiency associated with a rare form of dementia.

—Neflamapimod, an experimental EIP Pharma drug for Alzheimer’s disease, failed to achieve the main goal of improving episodic memory in a Phase 2 study. Boston-based EIP had licensed the compound from Vertex Pharmaceuticals (NASDAQ: VRTX), which had tested it in non-central nervous system diseases.

—SuperNus Pharmaceuticals (NASDAQ: SUPN) drug SPN-810 failed to beat a placebo in a Phase 3 study testing it as a treatment for impulsive aggression in patients age 6 to 11 with attention deficit hyperactivity disorder.


—Robin Isaacs is retiring as chief medical officer of Entasis Therapeutics (NASDAQ: ETTX), and will be succeeded by David Altarac… David Hollander was appointed chief research & development officer of Aerie Pharmaceuticals (NASDAQ: AERI)… Checkmate Pharmaceuticals appointed Kleem Chaudhary its chief business officer… Sung Lee left Gilead Sciences (NASDAQ: GILD) to become chief financial officer of Sangamo Therapeutics (NASDAQ: SGMO)… Acadia Pharmaceuticals (NASDAQ: ACAD) appointed Ponni Subbiah chief medical officer and senior vice president, global head of medical affairs… Abraham Scaria joined IVERIC bio (NASDAQ: ISEE) as chief scientific officer… Ashley Winslow was appointed chief scientific officer of Odylia Therapeutics… and Teva Pharmaceutical (NYSE: TEVA) named Eli Kalif its new executive vice president and chief financial officer.

Sarah de Crescenzo contributed to this report

Photo by Flickr user ollagrafik via a Creative Commons license