Catalyst Pharmaceuticals Inc (NASDAQ:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the initiation of a project to develop a generic equivalent of Sabril (vigabatrin). Sabril® is marketed by Lundbeck Inc. in the United States for the treatment of infantile spasms and complex partial seizures. Catalyst has substantial previous experience with its version of vigabatrin (CPP-109), which Catalyst believes will contribute to the rapid development and filing of an ANDA for a generic version of Sabril.
Patrick J. McEnany, Catalyst’s Chief Executive Officer said, “Catalyst remains extremely focused on the completion of the NDA submission for Firdapse® and on the development of other innovative drugs for the treatment of rare neurological and neuromuscular conditions.” Mr. McEnany continued, “However, we view the Sabril project as a complex, high barrier, generic program, in which we can leverage our extensive experience with our version of vigabatrin, enabling us to rapidly develop a product aligned with our neurological and neuromuscular rare disease focus. Furthermore, this product provides us with an opportunity to add additional shareholder value as we build a product portfolio for commercialization.”
To date, Catalyst has taken the following steps to develop this program:
- Catalyst has obtained the reference listed drug and the active pharmaceutical ingredient.
- Catalyst has entered into an exclusive supply agreement for the vigabatrin active pharmaceutical ingredient with a manufacturer that has filed a DMF, has validated the manufacturing process, and has prepared a number of batches of vigabatrin at commercial scale for Catalyst in the past. Catalyst believes that this manufacturer has an extensive and acceptable FDA inspectional history.
- The contract manufacturer of the finished dosage form has previously developed a manufacturing process for the drug product and prepared several commercial scale batches.
- Quality control and stability test methods for this product have already been developed and validated.
- Catalyst conducted a bioequivalence study in 2007 of its product formulation against the European equivalent of Sabril marketed by Sanofi Aventis, and those successful bioequivalence results were announced in a 2007 press release.
- Stability data has been collected for up to five years showing that Catalyst’s formulation has acceptable shelf life in more than one container closure system.
- Catalyst has an extensive body of clinical trial vision safety data from our previous studies with vigabatrin that we believe will be useful in designing a bioequivalence study that will be acceptable to both the U.S. FDA and an institutional review board (IRB).
Dr. Steven Miller, Catalyst’s Chief Operating Officer and Chief Scientific Officer said, “All of the data about vigabatrin that we collected when developing our version of vigabatrin (CPP-109) should be useful to us as we proceed quickly to perform a bioequivalence study of this product and, if successful, file an ANDA for this product.” Dr. Miller continued, “In addition to all the material advantages for the rapid development of this generic product, Catalyst’s management team, including our CEO, myself, and several other team members, have a long and successful history developing and commercializing generic drugs. We therefore, know how to complete this project in a timely manner, and expect to do so with minimal distraction from our primary focus of developing novel new drugs for rare diseases.” (Original Source)
Shares of Catalyst Pharmaceutical closed yesterday at $3.89. CPRX has a 1-year high of $5.80 and a 1-year low of $2.26. The stock’s 50-day moving average is $4.29 and its 200-day moving average is $4.18.
On the ratings front, Catalyst Pharmaceutical has been the subject of a number of recent research reports. In a report issued on August 12, Roth Capital analyst Scott Henry reiterated a Buy rating on CPRX, with a price target of $7, which represents a potential upside of 79.9% from where the stock is currently trading. Separately, on August 11, Piper Jaffray’s Charles Duncan reiterated a Buy rating on the stock and has a price target of $7.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Scott Henry and Charles Duncan have a total average return of 29.2% and 9.4% respectively. Henry has a success rate of 63.6% and is ranked #14 out of 3752 analysts, while Duncan has a success rate of 53.2% and is ranked #636.
Catalyst Pharmaceuticals Inc is abiopharmaceutical company. The Company is engaged in the development and commercialization of prescription drugs targeting rare (orphan) neurological diseases and disorders.