NEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ:MLNT]baxdela, is launching intravenous and oral formulations of Baxdela™ [delafloxacin] for the treatment of adult patients with acute bacterial skin and skin structure infections [ABSSSI] in the US.

Melinta has previously announced partnership agreements to launch Baxdela in numerous countries across the world, the FDA approved Baxdela in June 2017.

According to the company “no dosage adjustments are required due to weight, hepatic impairment or mild-moderate renal impairment, there are no food effects, and there is minimal potential for drug interactions,” with the drug.

Deborah DunsireNEW HAVEN: In an additional move to address what the activist investor Elliot Management said was a lack of bioscience experience on the company’s board, Alexion Pharmaceuticals Inc. [NYSE:ALXN] has appointed Deborah Dunsire, M.D. to the board.

Dr. Dunsire has served as President and Chief Executive Officer of Millennium Pharmaceuticals, Inc. from 2005-2013, which was sold to Takeda Pharmaceutical. Prior to Millennium, Dunsire led the Novartis North America Oncology Business, which according to the company’s release “grew in revenues from $50 million to more than $2.2 billion,” during her tenure.

healhtcareinnovationNEW HAVEN:The BioScience Pipeline Program, funded by Connecticut’s Quasi government venture capital firm Connecticut Innovations [CI], awarded grants to eight projects from local innovators affiliated with Yale University, the University of Connecticut (UConn), and Quinnipiac University.

The BioScience Pipeline program was founded in September 2015 to “enhance biomedical commercialization by providing milestone-based funding of up to $30,000 per project. In its fourth award round, this $500,000 per year pilot program provides critical funding to interdisciplinary ventures for business strategy, market definition, and prototyping activities. Awarded projects were selected based on their potential to create economic value and transform human health,” according to the news release of the awards by CI.

Half of the awards went to projects in the “digital healthcare space”, two of which include wearables.

RiluzoleTabs USP 50mg 60ctNEW HAVEN: Biohaven Pharmaceutical Holding Company Ltd. [NYSE:BHVN] announced positive results of its bioequivalence study with BHV-0223, what it calls an “innovative sublingual [can be taken without swallowing] formulation of riluzole.”

The study was designed to demonstrate “pharmacokinetic equivalence” of the company’s drug sublingual BHV-0223 compared to the reference listed drug Rilutek (riluzole), which is currently the standard of care treatment for patients with Amyotrophic Lateral Sclerosis (ALS).

Topline results confirmed that sublingual BHV-0223 (40 mg) achieved bioequivalent exposures relative to Rilutek (50 mg). In the study, 138 healthy volunteers were administered BHV-0223 and Rilutek under fasted conditions.

Opinion and Analysis

By Mitchell Young

Alexion Board Chair
David Brennan
Activist Investor,
Paul Elliott Singer

NEWHAVEN: Things are looking better at Alexion Pharmaceuticals [NASDAQ: Alxn] as the New Year begins. The collapse of the company’s stock from $149 to $105 has abated with a rise back to $125 a share as the year started.

The company announced on January 4th that it has made peace with activist investor Elliot Management. Elliot reportedly made a sizable investment in the company and according to a report in the New York Times wanted to see the company do more to increase the stock price including the possible sale of the company [see Activist Investor Targets Alexion].

Elliot also questioned the level of bioscience expertise on the board, a criticism we raised about the company’s board as well in early November 2017 in Alexion Sent On Market Tailspin Since Relocation, Reorganization Announcements.

Biostage 1st patientHARTFORD: Connecticut Children's Medical Center has made an investment in a small Massachusetts based biotech company Biostage, Inc. [OTCQB: BSTG/BSTGD]. The Center’s investment was part of a $4.2 million private placement. The current company’s market value is approximately $2.5 million. The hospital has reportedly made a $100,000 investment in the placement.

CCMC has several locations in Connecticut and at the Shriners Hospital and Baystate Medical [hospital] in Springfield, Mass.

Biostage says it is developing “bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea.” According to the company, the Children’s Medical Center was joined by a “group of investors from China.”

In October the company reduced its workforce by 71% [17 employees], in response to problems with another investment that didn’t materialize.

Screen Shot 2018 01 04 at 9.48.54 PMNEW HAVEN: The privately owned biotech Arvinas LLC, based on research by Yale’s Craig Crews, entered a license agreement and research collaboration with Pfizer Inc. [NYSE: PFE] potentially worth more than $830 million. The agreement is for the discovery and development of drug candidates using Arvinas' proprietary PROTAC (PROteolysis TArgeting Chimeras) Platform. The technology developed by Crews is what the company calls, “a novel technology used to create small molecule therapeutics aimed at degrading disease-causing cellular proteins.”

Crews was recognized by Business New Haven in 2014 as the Researcher of the Year, Healthcare Hero. Company Chairman Tim Shannon  led the founding investment for the company, he was recognized as a 2014 Healthcare Hero, Person of Merit as well.