Billionaire Paul Elliott Singer of Elliot Investment has been described as one of the country's toughest money managers and a vulture investor. His firm has targeted Alexion for changes or a possible sale.

By Mitchell Young

NEWHAVEN: All bets may be off at Alexion Pharmaceuticals [ NYSE: ALXN] as an activist investor announced it has taken a position in the company and is seeking major changes and potentially force a sale of the company.

According to the news site Fiercebiotech, Leerink Partners analyst Geoffrey Porges has called Alexion “one of the rare, once or twice per decade, activist investment situations in the biopharmaceutical industry.”

Apparently activist investor Elliott Management agrees, with the analyst, the New York Times, reports that Elliot has taken a position in the company and will likely press the company to do more to boost its share price.

In mid September the company’s stock price was $149 per share and analysts were recommending that it could reach $170 this year. New Alexion CEO Ludwig Hantson announced a new direction for the company on September 12 including a re-location of its headquarters to Boston and a restructuring of the company reducing the workforce by 20%.

The market reaction to the company’s financial guidance and new direction was not positive and the stock traded at just above $105 per share on December 7th.

The Times wrote that Elliot was seeking a more aggressive plan for the company including the potential sale of the company. The current market value of the company is approximately $25 billion. Revenue for the company and profits for the company have continued to grow, but Hantson’s guidance suggested it could slow down. Several companies have been working on new drugs that would target the same disease, paroxysmal nocturnal hemoglobinuria [PNH], that drives Alexion’s sales, including New Haven based Achillion Pharmaceuticals [Nasdaq: ACHN].

Reaction to the Elliot investment sent Alexion stock up 6% so far today [ December 8].

According to the Times, Elliot met with Alexion management in October and presented a list of four new potential board members for the company, a deadline for adding board members is imminent.

Alexion has responded to press inquiries saying, “Alexion believes in active and constructive dialogue with all of our shareholders, and we value their perspectives.”

Hantson’s restructuring already was cutting more than $250 million per year in expenses, even as the company’s drug development efforts in its core franchise were continuing to meet new success with regulators and the marketplace.

The relocation to Boston was proffered  by Hantson to allow the company to access that city’s biotech community to help develop new drug candidates. On December 7 the company announced a licensing deal with a down payment of $40 million [see Licensing] that would bolster the company’s core franchise’s ability to fend off competitors.

Early last month we wrote that the company needed to add more bioscience savvy executives to its Board, the Times reports that Elliot made that a demand as well at their meeting.

The company announced the addition of rare disease bio-science executive Francois Nader, M.D. on November 11, soon after the meeting with Elliott.

While the stock performance of the company has been very bad in the past few months, the company has received regulatory approvals for new uses of its franchise drug Soliris and has reported positive results on multiple clinical trials for its sales' challenged Kanuma drug and for its next generation Soliris replacement.

Alexion's Orloff, Head of Research inks his first licensing deal.

NEW HAVEN: Alexion Pharmaceuticals, Inc. [Nasdaq:ALXN] has entered into what can be a hundreds of millions of dollar licensing deal for drugs by Halozyme Therapeutics, Inc. [Nasdaq:HALO] a relatively small public biotech based in San Diego.

The agreement provides Alexion with the opportunity for “exclusive development of up to four targets, including a next generation subcutaneous formulation of ALXN1210," the company’s next generation [in development] replacement of Soliris, Alexion’s flagship drug.

Alexion will pay $40 million up front and potentially as much as $160 million for each of the four targeted therapies dependent on sales and regulatory milestones.

infectiousNEW HAVEN: Melinta Therapeutics, Inc. [NASDAQ: MLNT] has entered an agreement to acquire the infectious disease business from The Medicines Co. [NASDAQ: MDCO]. The acquisition includes the purchase of three marketable products - recently approved and launched Vabomere (vaborbactam/meropenem), and established commercial products Orbactiv (oritavancin), and Minocin IV (minocycline).

Melinta expects this transaction to create a “focused portfolio of high-value marketed assets with noteworthy commercial synergies.” Adding, “the combined infectious disease product portfolio of Melinta and The Medicines would enhance Melinta's multi-channel strategy of delivering antibiotic solutions for ABSSSI (acute bacterial skin and skin structure infections) and gram-negative infections within the hospital, emergency department, and community settings.”

migraineNEW HAVEN: Biohaven Pharmaceutical [NYSE: BHVN] has completed enrollment in Study BHV3000-302, the company’s second “pivotal Phase 3 clinical trial examining the efficacy and safety of rimegepant in the acute treatment of migraine.”

The company plans to announce its topline results for the migraine program in the first quarter of 2018. Together the two  trials enrolled approximately 3,000 subjects. The company says it expects the result “to support a robust assessment of the efficacy of rimegepant in the acute treatment of migraine as required by the FDA for registration.”

Investors are apparently waiting however, the company stock has pulled back to $22 per share on December 1, from its high of $39 in September. The company first went public in May of 2017 at $17.91 per share.

Vlad Coric, M.D., Chief Executive Officer at Biohaven, said, "Completion of enrollment in this second migraine trial in only about four months underscores both the priority of the CGRP program within Biohaven and the very high unmet need for innovative therapies to better treat migraine attacks.”

HEALERBRANFORD: Thetis Pharmaceuticals, a research level bio-tech founded in 2011 by by ex-Pfizer R&D executives and healthcare investors, announced the receipt of a Fast-Track Small Business Innovation Research (SBIR) Grant from the National Institutes of Health for $2.3 million.. The grant will support development of Thetis’ TP-317 candidate as oral therapy for treatment of ulcerative colitis.

Thetis CEO Mathias: "A fundamentally new approach."

Gary Mathias, Co-founder and Chief Executive Officer, said, “TP-317 offers a fundamentally new approach to IBD treatment based on active resolution of inflammation and the promotion of tissue regeneration without suppressing the immune system. The grant will support the advancement of this promising, potential new therapy into the clinic.”

Preclinical efficacy studies are being conducted in collaboration with Dr. Daniel Rosenberg, Professor of Medicine at the University of Connecticut. Dr. Rosenberg commented: “TP-317 delivers a natural bioactive lipid known as Resolvin E1 that regulates the inflammatory response.”

Thetis is funded by Connecticut Innovations, Inc. and is a member of the Technology Incubation Program at University of Connecticut Health.

Dr. Vince O’Neill, Chief Medical Officer of BioXcel Therapeutics, says company potentially breaking new ground in cancer treatment.

BRANFORD: BioXcel Therapeutics (“BTI”), a research stage [founded in 2005], announced a research collaboration with San Francisco based the publicly traded Nektar Therapeutics [Nasdaq: NKTR] with a $6 billion market cap, research/development stage bio-tech.

The companies will “explore the novel combination of Nektar’s NKTR-214, a CD122-biased agonist, and BTI’s BXCL701, a small molecule immune-modulator and DPP 8/9 and FAP inhibitor, for the treatment of multiple oncology indications.”

According to the companies, the goal of this collaboration is to leverage “the complementary mechanisms of NKTR-214 and BXCL701 to boost the body’s own immune system and overcome local immunosuppressive mechanisms in the tumor microenvironment. The collaborative research studies will evaluate the potential of the therapies in preclinical mouse models of pancreatic and prostate cancer.”

bioscience roadmapNEW HAVEN: Two New Haven based biotechs, Melinta Therapeutics [Nasdaq:MLNT] and Biohaven [NYSE:BHVN] have both just begun new clinical trials.

Melinta Therapeutics, Inc. which has developed the FDA approved antibiotic Baxelda, to treat MRSA and other skin infections, has initiated a Phase 2 clinical study of topical Radezolid for the treatment of mild-to-moderate acne vulgaris.

The Melinta study will enroll approximately 48 individuals with moderate-to-severe facial acne vulgaris. The company hopes to demonstrate that the twice daily application will create at least an “almost clear” condition. The study is expected to complete enrollment in the second half of 2018.