On Thursday June 18, 2015, we posted an article under “Today’s Highlights” at the Prohost website about an important agreement Biocryst Pharmaceuticals (BCRX) signed with CSL We expect the agreement to contribute a great deal into bringing effective treatments of disabling chronic progressive diseases and life-threatening acute diseases to the global market
The news that appealed to us and the market came in the announcement by Biocryst Pharmaceuticals that ithas licensed to the Company CSL Limited its drug Rapivab (peramivir injection), which aims at treating influenza. Rapivab is an intravenous (I.V.) viral neuraminidase inhibitor. It was recently approved in the U.S. for acute uncomplicated influenza in adults 18 years and older. It is being licensed for use in Japan and Korea.
The terms of the Biocryst / CSL agreement
– Offering bioCSL worldwide rights to commercialize Rapivab with the exception of Japan, Korea, Taiwan and Israel.
– Biocryst retains all rights to pursue pandemic stockpiling orders for Rapivab from the U.S. government, while bioCSL is responsible for government stockpiling outside the U.S.-
– Biocryst receives an upfront payment of $33.7 million from bioCSL, and may receive up to $12.0 million in additional payments related to the successful achievement of certain regulatory milestones.
– Biocryst will receive tiered royalties that are contingent upon certain net sales thresholds in the U.S. and the rest of the world, as well as a percentage of proceeds from government stockpiling purchases outside the U.S.
– bioCSL will purchase existing and in-process inventory of Rapivab for treatment of influenza patients in upcoming flu seasons.
We remind that Rapivab is not a preventive, but a treatment of acute influenza.
Biocryst designs, optimizes and develops novel small molecule drugs that block key enzymes in the pathways of diseases and in infectious diseases. The firm’s goal is addressing unmet medical needs in life-threatening and disabling diseases.
BCX4430 — a broad spectrum antiviral for hemorrhagic fevers. The drug is the firm’s lead infectious disease product and has already demonstrated broad-spectrum activity in multiple viruses and a favorable safety profile in preliminary trials. Biocryst is now developing BCX4430 in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). In September 2013, NIAID signed an agreement with Biocryst to develop of BCX4430 for Marburg virus disease and potentially for other filoviruses, including Ebola.
Hereditary Angioedema (HAE)
BCX4161 — inhibits plasma kallikrein and bradykinin production. Bradykinin is the mediator of
acute swelling attacks in hereditary angioedema (HAE) patients.
Results: Phase 2a proof of concept clinical the trials from OPuS-1 (Oral ProphylaxiS-1) met the primary efficacy endpoint, several secondary endpoints and all other trial objectives. Treatment with BCX4161 demonstrated a statistically significant mean attack rate reduction per week versus placebo.
Currently ongoing trials: OPuS-2 (Oral ProphylaxiS-1). OPuS-2 is a 12-week trial, which started enrolling patients in December 2014. The trial is three-arm, parallel cohort design trial to evaluate the efficacy and safety of two different dose regimens of BCX4161 administered three-times daily, 300 mg and 500 mg, compared with placebo.
Second Generation plasma kallikrein inhibitors:
BX7353: In December 2013, Biocryst selected two optimized next generation kallikrein inhibitors to advance into preclinical development for the treatment of HAE. Scientists are excited over the evidence of the drug’s superior bioavailability, selectivity, and potency compared to BCX4161.
On May 13, 2015 Biocryst initiated human testing with BCX7353, its lead second-generation kallikrein inhibitor and expects to report safety and pharmacokinetics results during the 3rd quarter 2015.
Biocryst’s flu drug Rapivab needed an expert to successfully market it globally. Licensing Rapivab to CSL, Biocryst might have hit the Jackpot regarding the global marketing of its influenza drug. CSL is a subsidiary, bioCSL, a global manufacturer that in-licenses, markets and distributes vaccines for the prevention and treatment of serious disease, especially influenza. bioCSL operates one of the world’s largest influenza vaccine manufacturing facilities and supplies seasonal influenza vaccines to Australia and global markets. It also Works closely with public health authorities and the Australian Department of Health & Ageing and successfully negotiate government influenza stockpiling contracts around the globe.
In addition to providing Biocryst with non-dilutive capital, CSL promises comprise bringing additional approvals of Rapivab in Europe, Canada and the rest of the world markets, thus maximizing the potential value of Rapivab.
Biocryst licensing agreement is a major management achievement. It opens the door wide for Rapivab to enter the global markets. The jackpot would grow much larger in case a similar agreement would be signed between the two firms to cover Biocryst’s other products, especially thebroad-spectrum oral or injectable drugs against viruses that pose a threat to health and national security. Biocryst goals are the same as bioCSL declared objectives.
Among Biocryst attractive projects is developing small-molecule antiviral drugs directed against viral RNA polymerase — a component of RNA viruses that plays a crucial role in viral replication, transcription and replication of the virus genome. This approach could enable one drug to replace multiple, specific drugs to be used in natural viral outbreaks and bioterrorist threats.
Friday Closing Price: $15.61
Market Cap.: $1.3 Billion
Revenues per share: 0.24
Quarlr Rev. Growth: 97.40%
Growth Profit: $13.61 M
Diluted EPS: – 0.72
Total Cash: $67.53 M
52-Week High (Jun 19, 2015): $15.83 on Friday June 19, 2015 closing price
52-Week Low (Mar 26, 2015): $7.85
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