First Alzheimer`s drug from Eisai/UCL alliance to enter clinical trials

The first drug candidate from Eisai and University College London (UCL)s drug discovery collaboration is to enter Phase I clinical trials for Alzheimers disease (AD) early next year.

The candidate drug, known as E2814, is an anti-tau monoclonal antibody set to be tested in human trials for the first time to assess its ability to slow the progression of AD.

The research partnership between Eisai and UCL was agreed in 2012 for an initial period of six years, but has been extended for a further five years to 2023.

E2814 is one outcome out of a portfolio of projects established during the first phase of the collaboration, designed to prevent the spreading of tau protein seeds spread between different areas of the brain as the disease advances within affected individuals.

This prevents further build-up of neurofibrillary tangles, and as a result may slow the course of the disease.

Andy Takle, executive director and head, Eisai Hatfield Research Laboratories said: The discovery is the result of a truly open partnership with UCL. We are proud that our collaboration has led to the discovery of E2814, which will progress into clinical trials early next year.

This achievement would not have been possible without the unique collaboration model we have built based on a continued exchange of ideas, and sharing of expertise and resources.

There is currently no cure for dementia, a disease that 850,000 people live with in the UK, with numbers set to rise to over one million by 2025. It is believed AD accounts for up to 70% of all dementia cases.

https://www.marketscreener.com/EISAI-CO-LTD-6492461/news/Eisai-First-Alzheimer-s-drug-from-Eisai-UCL-alliance-to-enter-clinical-trials-27720999/

Quidel: Comments on California Court Ruling

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that the San Diego Superior Court (the “Court”) stated that it intends to enter an order granting Beckman’s motion for summary adjudication relating to the agreement for the supply of antibodies and other inputs related to, and distribution of, the Triage® BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, between Quidel and Beckman (the “Beckman Agreement”). Specifically, the Court stated that it intends to rule that a provision of the Beckman Agreement restricting Beckman from manufacturing or selling another BNP or NT-proBNP assay is void as a matter of law. The remainder of the Beckman Agreement remains in effect. Beckman will continue to supply Quidel, and Quidel will continue to sell, the underlying BNP assay.

“The ruling does not end the litigation, as it concerns only one aspect of the case. Quidel intends to promptly request that the Court stay its order, and it intends to request that the Fourth District Court of Appeal immediately review the decision,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “Our overall view of the litigation remains unchanged, and we continue to believe that Beckman’s position is meritless, in opposition to Beckman’s long-standing strategy over the last 15 years of honoring the Beckman Agreement with its previous partners – Alere and Biosite. The Court’s ruling today does not change our view that Quidel will ultimately prevail in the litigation on the merits through motion, or at trial, which is currently scheduled for August 30, 2019.”

Conference Call Information

Quidel management will host a conference call to discuss the matter on Monday morning, December 10, 2018 beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). During the conference call, management may answer questions regarding the intended ruling. Quidel’s responses to these questions, as well as other matters discussed during the conference call, may contain or constitute material information that has not been previously disclosed.

https://www.marketscreener.com/QUIDEL-CORPORATION-10595/news/Quidel-Comments-on-California-Court-Ruling-27723798/

San Antonio Breast Cancer to hold a symposium

San Antonio Breast Cancer Symposium 2018 will be held in San Antonio, TX on December 3-8.

https://thefly.com/landingPageNews.php?id=2831171

Piper remains buyers of Alnylam following recent weakness

Alnylam Pharmaceuticals’ R&D day highlighted the the transition into a commercial stage company with multiple late stage programs, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. Alnylam is expanding RNAi drug discovery outside of the liver into central nervous system and cardiovascular disease, adds the analyst. He says Piper remains buyers of Alnylam on recent weakness ahead of new RNAi drug approvals and data read-outs. Tenthoff reiterates an Overweight rating on the stock with a $160 price target.

https://thefly.com/landingPageNews.php?id=2833498

Corbus Pharmaceuticals initiated at RBC Capital

Corbus Pharmaceuticals initiated with an Outperform at RBC Capital. RBC Capital analyst Brian Abrahams initiated Corbus Pharmaceuticals with an Outperform rating and a price target of $23. The analyst believes that the current valuation on its stock “substantially underappreciates the broad potential of lead drug lenabasum across multiple high unmet need autoimmune/inflammatory conditions”. Abrahams also sees potential for share appreciation ahead of the company’s late-stage readouts, with “significant upside” coming in late 2019 and early 2020 if Corbus’ Phase 2 trial data show benefits in systemic sclerosis and dermatomyositis studies.

https://thefly.com/landingPageNews.php?id=2833562

Regeneron price target raised to $483 from $473 at Leerink

Leerink analyst Geoffrey Porges maintained an Outperform rating on Regeneron and raised his price target to $483 from $473. In a research note to investors, Porges says that he believes it is “appropriate” to include some revenue for the Libtayo indication in NSCLC in his forecast and valuation. Including this revenue, which commences in 2022, Porges is raising his long-term revenue forecast for Regeneron by $313M. Based on the strong data that has led to the recent FDA approval in cutaneous squamous cell carcinoma, or CSCC, and the promising early data in other tumor types, the analyst says he is increasingly confident that Libtayo is a potent PD-1 blocking agent with comparable activity to the approved anti-PD-1s, Keytruda and Opdivo. He says that Even though Regeneron is likely to be a late entrant to the lung cancer market compared to the established players, even a relatively small minority market share will generate significant value for the company and its partner.

https://thefly.com/landingPageNews.php?id=2833654

ANI Pharmaceuticals enters agreements with certain holders of convertible notes

ANI Pharmaceuticals announced that it has entered into separate, privately negotiated agreements with certain holders of its outstanding 3.00% Convertible Senior Notes due 2019. ANI has agreed to repurchase $25M aggregate principal amount of Notes for a total of $26.1M in cash, including accrued but unpaid interest up to but excluding the closing date for the transactions. In connection with the contemplated repurchase of Notes, ANI has also entered into an agreement with the dealer party to certain convertible note hedge transactions related to the Notes to unwind a corresponding portion of such convertible note hedge transactions. ANI has also entered into agreements with such dealer counterparty to unwind certain warrant transactions in amounts corresponding to the portion of the Notes outstanding being repurchased.

https://thefly.com/landingPageNews.php?id=2833673