Repros Therapeutics RPRX suffered a setback with the FDA issuing a complete response letter (CRL) for the company’s lead pipeline candidate. Meanwhile, AbbVie’s ABBV oncology segment got a boost with the FDA approving its multiple myeloma drug.
Recap of the Week’s Most Important Stories
1. It’s back to the drawing board for Repros which received a CRL from the FDA for enclomiphene. Repros was looking to get enclomiphene approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.
But the FDA has made it clear that the design of the phase III studies on enclomiphene is no longer enough to show clinical benefit. The regulatory agency recommended that Repros should conduct an additional phase III study or studies to support approval in the target population. Other concerns raised by the FDA were about study entry criteria, titration and bioanalytical method validation in the phase III program.
While Repros shares were down more than 27%, the CRL does not really come as a surprise considering the FDA had cancelled an advisory panel meeting that was scheduled to take place in November.
2. AbbVie and partner Bristol-Myers Squibb gained FDA approval for their blood cancer treatment, Empliciti. Empliciti is currently under review in the EU where it received accelerated assessment. Multiple myeloma remains largely incurable with less than 50% of patients surviving for 5 years or more after diagnosis. (Read more: AbbVie/Bristol-Myers Multiple Myeloma Drug Gets FDA Nod).
3. Biotech major Amgen AMGN, which is currently facing biosimilar competition for one its key drugs in the U.S., is progressing in its own efforts to bring biosimilars to market. The company has filed a BLA for ABP 501, its biosimilar version of AbbVie’s Humira (adalimumab). Amgen believes it is the first to submit a BLA for a Humira biosimilar.
At an analyst conference in Oct 2015, Amgen said that its biosimilars have the potential to generate revenues of more than $3 billion annually. Apart from Humira, Amgen is working on developing biosimilar versions of drugs like Avastin, Herceptin, Remicade, Rituxan and Erbitux (Read more: Amgen Seeks FDA Approval for First Biosimilar of Humira).
4. XOMA XOMA has struck a deal with Novo Nordisk which could bring in up to $295 million (including an upfront payment of $5 million) and tiered royalties. In return, Novo Nordisk gets exclusive global rights to XOMA’s XMetA program for the treatment of diabetes. Commercialization rights for rare disease indications remain with XOMA.
5. Results from an 18-month investigation into the pricing and marketing of Gilead’s GILD blockbuster hepatitis C virus (HCV) drugs Sovaldi and Harvoni were released by Senate Finance Committee Ranking Member Ron Wyden, D-OR, and senior committee member Chuck Grassley, R-IA.
Based on information taken from internal company documents, interviews with health care experts, and data from Medicaid programs in 50 states and the District of Columbia, the investigation showed that Gilead’s marketing strategy and final wholesale price of Sovaldi ($1,000 per pill or $84,000 for a single course of treatment; Harvoni was later introduced at $94,500) was based on revenue maximization.
The investigation indicated that encouraging broad, affordable access was not a key consideration in the process of setting the wholesale prices. The report also stated that Medicare spent more on Gilead HCV drugs in the first half of 2015 than in all of 2014. This report once again brings into focus concerns regarding the pricing of drugs.
Performance
Alexion ALXN was the highest gainer (1.39%) among major biotech stocks over the last five trading days while Regeneron declined 3.83% during this period. Meanwhile, Biogen BIIB lost 26.94% over the last six months with Alexion being the highest gainer (10.03%) during this period.
The NASDAQ Biotechnology Index was up 0.28% over the last five trading days (See the last biotech stock roundup here: KaloBios Soars as Shkreli Steps In, FDA Panel Not Convinced about BioMarin Drug).
| Company | Last Week | Last 6 Months |
| AMGN | -0.49% | 4.67% |
| BIIB | 0.31% | -26.94% |
| GILD | -0.68% | -5.01% |
| CELG | -1.87% | -3.39% |
| REGN | -3.83% | 6.47% |
| ALXN | 1.39% | 10.03% |
| VRTX | -2.08% | 1.61% |
What's Next in the Biotech World?
Alexion, which will be hosting an Investor Day next week, also has an important regulatory event coming up with the FDA expected to respond on the approval status of Kanuma (treatment of lysosomal acid lipase deficiency) by Dec 8.
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