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PRTA Jolted, FDA Strikes Down PFE's Herceptin Biosimilar, No Relief Yet For KMDA

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Today's Daily Dose brings you news about Prothena pulling the plug on its AL amyloidosis drug candidate NEOD001; FDA panel thumbs up for lower dose of Baricitinib; imposition of FDA's partial hold on Epizyme's Tazemetostat program; FDA striking down Pfizer's Herceptin biosimilar, and delay in initiation of Kamada's phase III clinical study of Inhaled AAT for treatment of alpha-1 antitrypsin deficiency.

Read on…

Celgene Corp. (CELG) has extended its collaboration with Zymeworks Inc. (ZYME), which was signed in January 2015, for the research, development, and commercialization of bi-specific antibody therapeutics based on Zymeworks' proprietary Azymetric platform.

Under the expanded deal, Celgene has now exercised its right to increase the number of potential products it can develop and commercialize from eight to ten, and extended the research program term by two years.

Zymeworks will receive an expansion fee and is now eligible to receive up to US$164 million in development and commercial milestones for each of up to 10 products plus royalties on worldwide sales. In total, Zymeworks is now eligible to receive up to US$1.64 billion in future payments for the entire collaboration.

You can find more about ZYME in our Company Spotlight column.

ZYME closed Monday's trading at $12.14, up 1.34%.

An FDA panel has recommended approval of Baricitinib 2mg, but not 4mg, for the treatment of moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate.

Baricitinib, a once-daily oral JAK inhibitor, is co-developed by Eli Lilly (LLY) and Incyte Corp. (INCY).

The FDA's final decision on Baricitinib is expected to be announced in June 2018.

Baricitinib 2-mg and 4-mg doses are approved in more than 40 countries, including the member states of the European Union and Japan.

INCY closed Monday's trading at $68.14, down 0.42%.

Enrollment of new patients in Epizyme Inc.'s (EPZM) U.S. clinical trials of Tazemetostat has been put on temporary hold.

Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied as a monotherapy in ongoing Phase 1 and 2 programs in certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of NHL; mesothelioma; and combination studies in DLBCL and non-small cell lung cancer (NSCLC).

The FDA initiated a partial hold following a safety report of a pediatric patient who developed a secondary lymphoma in the company's phase I pediatric study of Tazemetostat.

Doses explored in the pediatric study are higher than those in the phase II adult studies, according to the Company.

More than 750 patients have been treated with Tazemetostat to date, and this is the only case of secondary lymphoma that has been observed across the Tazemetostat clinical program, noted the Company.

EPZM closed Monday's trading at $15.30, down 3.47%. In after=hours, the stock was down 17.65% to $12.60.

Kamada Ltd. (KMDA) has decided to delay the initiation of its phase III clinical study of Inhaled AAT for treatment of alpha-1 antitrypsin deficiency (AATD), originally scheduled in the second half of 2018, until it hears from the FDA again.

The delay comes in the wake of the FDA expressing continued concerns and questions related to the safety profile of Inhaled AAT.

In response to a proposed phase III study protocol for Inhaled AAT for treatment of AATD, which was submitted last July, the FDA had expressed concerns and questions regarding the safety and efficacy of Inhaled AAT for the treatment of AATD and the risk/benefit balance to patients.

In March 2018, following further discussions and based on additional feedback received from the FDA, Kamada submitted a revised pivotal Phase 3 protocol to the FDA, as well as additional information related to the FDA questions and concerns.

But this time too, the FDA is not satisfied, forcing the Company to delay the initiation of the phase III trial.

The Company is expecting to present its planned Phase 3 protocol in a Scientific Advice meeting with the European Medicines Agency in the third quarter of 2018, in order to obtain feedback and guidance in connection to the regulatory path for Inhaled AAT in Europe.

KMDA closed Monday's trading at $4.52, down 0.55%.

The FDA has turned down Pfizer Inc.'s (PFE) Biologics License Application for its proposed version of Herceptin biosimilar.

Herceptin is Roche's blockbuster drug indicated for the treatment of breast cancer.

Pfizer has been asked to provide additional technical information before its proposed Herceptin biosimilar could be approved. The additional requested information does not relate to safety or clinical data submitted in the application.

MYL-1401O, co-developed by Mylan and Biocon, approved last December, is the first Herceptin biosimilar to be greenlighted in the U.S.

In other news, the Company announced that the European Commission has approved MYLOTARG for the treatment of previously untreated, de novo, CD33-positive Acute Myeloid Leukemia in combination with chemotherapy. MYLOTARG received FDA approval in September 2017 for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

PFE closed Monday's trading at $36.80, up 0.46%.

Shares of Prothena Corp. plc (PRTA) slumped more than 68% on Monday, following disappointing news related to NEOD001, its investigational antibody that was being evaluated for the treatment of AL amyloidosis.

The Company announced that its phase IIb clinical study of NEOD001 vs. placebo in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction, dubbed PRONTO, did not meet its primary or secondary endpoints.

But that's not all…

Prothena is also discontinuing its phase III clinical study of NEOD001 vs. placebo in treatment-naïve patients with AL amyloidosis and cardiac dysfunction, dubbed VITAL, based on the recommendation of the independent data monitoring committee.

PRTA closed Monday's trading at $11.50, down 68.78%. In after-hours, the stock was up 0.87% to $11.60.

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