BIIB Pulls Plug On Parkinson’s Drug, JAZZ Acquires GWPH, NBIX Ends Deal With VYGR, TYME Flies
Today’s Daily Dose brings you news about Biogen pulling the plug on a potential Parkinson’s drug, Jazz Pharma acquiring GW Pharmaceuticals, Neurocrine terminating its agreement with Voyager related to Parkinson’s disease drug development, and Vaxart’s phase I study results of oral COVID-19 tablet vaccine candidate.
1. Biogen throws in the towel on potential Parkinson’s Drug
Biogen Inc. (BIIB) has discontinued the development of BIIB054 (Cinpanemab), a potential Parkinson’s drug, following the failure of that compound in a phase II study.
The phase II study of BIIB054, dubbed SPARK, has not met its primary or secondary endpoints. The company has recognized an impairment charge of approximately $75.4 million during the fourth quarter of 2020, as a result of terminating BIIB054.
The company’s controversial Alzheimer’s disease drug candidate Aducanumab awaits the FDA decision in early June. An FDA panel, which reviewed Aducanumab, last November, had recommended against approving Aducanumab for the treatment of Alzheimer’s.
Looking ahead to 2021, Biogen expects full year revenue to be between $10.45 billion and $10.75 billion, and non-GAAP EPS to be between $17.00 and $18.50. This compares with revenue of $13.44 billion and non-GAAP EPS of $33.70 in 2020.
BIIB closed Wednesday’s trading at $263.25, down 5.21%.
2. Jazz Loosens Purse Strings
Jazz Pharmaceuticals plc (JAZZ) has agreed to acquire GW Pharmaceuticals plc (GWPH) for $220.00 per American Depositary Share, which equates to a total consideration of $7.2 billion.
As part of the deal, holders of GW ADSs will be entitled to receive $200.00 in cash and $20.00 in Jazz ordinary shares for each GW ADS.
GW Pharma’s lead product, Epidiolex (cannabidiol) oral solution, is approved in patients one-year and older for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome and Tuberous Sclerosis Complex (TSC), all of which are rare diseases characterized by severe early-onset epilepsy. The company’s pipeline includes Nabiximols, which is under phase 3 trials for treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as earlier-stage cannabinoid product candidates for autism and schizophrenia.
The acquisition of GW Pharma adds high-growth commercial franchise to Jazz Pharma’s Neuroscience portfolio and is anticipated to be accretive in first full year of combined operations and substantially accretive thereafter.
The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.
GWPH closed at an all-time high of $211.37, up 44.53%.
3. Neurocrine Ends Parkinson’s Pact with Voyager
Neurocrine Biosciences Inc. (NBIX) has terminated the agreement with Voyager Therapeutics, Inc. (VYGR) for the development of NBIb-1817 (also known as VY-AADC) in Parkinson’s disease, effective August 2, 2021.
NBIb-1817 was in a phase II trial , dubbed RESTORE-1, when the FDA slapped a clinical hold on the trial last December after the company reported MRI abnormalities in some RESTORE-1 study participants.
In January 2019, the two companies formed a collaboration focused on the development and commercialization of Voyager’s gene therapy programs, VY-AADC for Parkinson’s disease and VY-FXN01 for Friedreich’s ataxia, as well as rights to two additional programs.
The collaboration has been called off only for the Parkinson’s disease and the agreement will otherwise continue in effect.
VYGR closed Wednesday’s trading at $7.49, down 6.38%.
4. Tyme Soars On New Patent For COVID-19 Treatment
Tyme Technologies Inc. (TYME) has been granted additional patent claims covering the use of TYME-19 to treat COVID-19 infections.
TYME-19 constrains viral replication after a virus has inserted its genetic blueprint into an infected cell by inhibiting the ability of the virus to use the cells synthetic apparatus to make viral proteins and lipid, according to the company.
The company intends to initiate the appropriate clinical trials to substantiate the safety and efficacy of TYME-19.
The company’s lead drug candidate is SM-88, an oral investigational modified proprietary tyrosine derivative.
A pivotal trial of SM-88 as a potential treatment for third-line pancreatic cancer, dubbed TYME-88-Panc, and a phase II/III registration-intent trial of SM-88 as second-line monotherapy for pancreatic cancer, which is part of PanCAN Precision Promise clinical trials framework, are ongoing. The data readouts from the trials are expected in 2022.
TYME closed Wednesday’s trading at $3.53, up 93.96%.
5. Vaxart Reports Phase I Trial Results of Oral COVID-19 tablet vaccine
Shares of Vaxart Inc. (VXRT) plunged nearly 58% Wednesday after the company announced preliminary data from a phase I study of its oral COVID-19 tablet vaccine candidate VXA-CoV2-1.
The study participants were divided into three cohorts. The first cohort (5 subjects) received two low doses of the oral COVID-19 tablet vaccine 29 days apart. The remaining cohorts (15 subjects each) received a single low or high dose of the vaccine.
Although the study reached primary and secondary endpoints of safety and immunogenicity, respectively, with the oral vaccine candidate VXA-CoV2-1 generating robust CD8 T cell responses, it did not induce serum neutralizing antibodies. In most of the approved vaccines, neutralizing antibodies correlate to vaccine efficacy.
The lack of neutralizing antibodies associated with the vaccine has displeased investors, who drove the stock price down.
The company plans to explore VXA-CoV2-1 in phase II studies n COVID-19 naïve subjects to evaluate optimal dosing schedule and to then assess efficacy against COVID-19. VXA-CoV2-1 is also expected to be studied in previously vaccinated or exposed subjects to investigate single dose boosting protocol to broaden and strengthen immune response.
VXRT closed Wednesday’s trading at $9.85, down 57.78%.
6. Some of the Top Gainers/Losers of the Day
Clene Inc. (CLNN) closed Wednesday’s trading at $13.21, up 101.68%.
Cassava Sciences Inc. (SAVA) closed at $87.95, up 58.64%.
Anavex Life Sciences Corp. (AVXL) closed at $10.38, up 37.85%.
Vaxart Inc. (VXRT) closed at $9.85, down 57.78%.
Ocugen Inc. (OCGN) closed at $2.81, down 13.80%.
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