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Biotech Stock Roundup: GWPH Submits Epidiolex in the EU, Sangamo Inks Deal with Pfizer
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Although it was a slow week, a few companies announced collaboration agreements. Meanwhile, Ligand Pharmaceuticals (LGND - Free Report) raised its guidance for 2017 and GW Pharmaceuticals got priority review in the United States for Epidiolex.
Recap of the Week’s Most Important Stories
GW’s Epidiolex Submitted for EU Approval: GW Pharmaceuticals, which has been in the news for its lead cannabinoid pipeline candidate, Epidiolex (cannabidiol or CBD), said that it has submitted a regulatory application to the European Medicines Agency (“EMA”) for Epidiolex as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (“LGS”) and Dravet syndrome. Both are highly treatment-resistant forms of childhood-onset epilepsy. The company has Orphan Designations in the EU for Epidiolex for these two indications as well as West syndrome and tuberous sclerosis complex.
The company is also seeking approval in the United States for the LGS and Dravet syndrome indications. With the regulatory agency granting priority review, a response is expected by Jun 27, 2018. Epidiolex represents blockbuster potential especially if it is approved across all possible indications.
Ligand Ups 2017 View on Payment from OmniAb Partner: Ligand raised its guidance for 2017 with the company earning $6 million from partner, HanAll Biopharma. HanAll said that it has out-licensed antibody projects that were discovered by the company using Ligand’s OmniAb antibody discovery platform.
Ligand said that it now expects to earn $3.13 - $3.16 per share on total revenue of approximately $140 million in 2017. The company was previously expecting earnings of $2.95 - $3.00 per share on revenues of $134 - $136 million.
Priority Review for Label Expansion of Seattle Genetics’ Adcetris: Seattle Genetics got priority review for its supplemental Biologics License Application (“BLA”) for Adcetris plus chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. Given the priority review status, a response should be out by May 1, 2018. Expansion into the front-line setting should boost product sales. For the first nine months of 2017, Adcetris sales (as recorded by Seattle Genetics) were $223.8 million.
Sangamo-Pfizer Sign Another Collaboration Agreement: Sangamo Therapeutics (SGMO - Free Report) and Pfizer are collaborating for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) for the treatment of amyotrophic lateral sclerosis (“ALS”) and frontotemporal lobar degeneration (“FTLD”) linked to mutations of the C9ORF72 gene. The agreement will see Sangamo receiving an upfront payment of $12 million from Pfizer as well as milestone payments worth up to $150 million plus tiered royalties on net sales.
While Sangamo will be responsible for the development of ZFP-TF candidates, Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization for the C9ORF72 ZFP-TF program and other resulting products.
Sangamo and Pfizer already have a collaboration agreement that was announced last year for the development and commercialization of gene therapy products for hemophilia A, including SB-525.
Sangamo’s shares are up 404.3% over the last one year compared to the 3.8% gain recorded by the industry it belongs to.
UTHR in Licensing Agreement with Corsair Pharma: United Therapeutics (UTHR - Free Report) , a key player in the pulmonary arterial hypertension (“PAH”) market, announced an exclusive license agreement with Corsair Pharma for the latter’s portfolio of patents covering treprostinil prodrugs.
In addition to getting an upfront payment, Corsair will receive royalty payments on the commercialization of treprostinil prodrug products by United Therapeutics that are covered by Corsair's patents. The agreement terms also include an equity investment by United Therapeutics in Corsair.
Spark Provides Update on Luxturna: Spark Therapeutics has priced its one-time gene therapy treatment, Luxturna, at $850,000. However, the company also announced three new payer programs that are expected to lower the financial burden for patients as well as treatment centers. The company has been working with health insurers to ensure access to Luxturna (Read more: Spark Therapeutics Hopes to Cure a Rare Blindness for $850,000 a Pop).
Luxturna was approved in December 2017 for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. According to the FDA, biallelic RPE65 mutation-associated retinal dystrophy affects approximately 1,000 to 2,000 patients in the United States.
Watch out for updates and outlooks that will be provided by several companies next week at the 36th Annual J.P. Morgan Healthcare Conference.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Biotech Stock Roundup: GWPH Submits Epidiolex in the EU, Sangamo Inks Deal with Pfizer
Although it was a slow week, a few companies announced collaboration agreements. Meanwhile, Ligand Pharmaceuticals (LGND - Free Report) raised its guidance for 2017 and GW Pharmaceuticals got priority review in the United States for Epidiolex.
Recap of the Week’s Most Important Stories
GW’s Epidiolex Submitted for EU Approval: GW Pharmaceuticals, which has been in the news for its lead cannabinoid pipeline candidate, Epidiolex (cannabidiol or CBD), said that it has submitted a regulatory application to the European Medicines Agency (“EMA”) for Epidiolex as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (“LGS”) and Dravet syndrome. Both are highly treatment-resistant forms of childhood-onset epilepsy. The company has Orphan Designations in the EU for Epidiolex for these two indications as well as West syndrome and tuberous sclerosis complex.
The company is also seeking approval in the United States for the LGS and Dravet syndrome indications. With the regulatory agency granting priority review, a response is expected by Jun 27, 2018. Epidiolex represents blockbuster potential especially if it is approved across all possible indications.
Ligand Ups 2017 View on Payment from OmniAb Partner: Ligand raised its guidance for 2017 with the company earning $6 million from partner, HanAll Biopharma. HanAll said that it has out-licensed antibody projects that were discovered by the company using Ligand’s OmniAb antibody discovery platform.
Ligand said that it now expects to earn $3.13 - $3.16 per share on total revenue of approximately $140 million in 2017. The company was previously expecting earnings of $2.95 - $3.00 per share on revenues of $134 - $136 million.
Priority Review for Label Expansion of Seattle Genetics’ Adcetris: Seattle Genetics got priority review for its supplemental Biologics License Application (“BLA”) for Adcetris plus chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. Given the priority review status, a response should be out by May 1, 2018. Expansion into the front-line setting should boost product sales. For the first nine months of 2017, Adcetris sales (as recorded by Seattle Genetics) were $223.8 million.
Sangamo-Pfizer Sign Another Collaboration Agreement: Sangamo Therapeutics (SGMO - Free Report) and Pfizer are collaborating for the development of a potential gene therapy using zinc finger protein transcription factors (ZFP-TFs) for the treatment of amyotrophic lateral sclerosis (“ALS”) and frontotemporal lobar degeneration (“FTLD”) linked to mutations of the C9ORF72 gene. The agreement will see Sangamo receiving an upfront payment of $12 million from Pfizer as well as milestone payments worth up to $150 million plus tiered royalties on net sales.
While Sangamo will be responsible for the development of ZFP-TF candidates, Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization for the C9ORF72 ZFP-TF program and other resulting products.
Sangamo and Pfizer already have a collaboration agreement that was announced last year for the development and commercialization of gene therapy products for hemophilia A, including SB-525.
Sangamo’s shares are up 404.3% over the last one year compared to the 3.8% gain recorded by the industry it belongs to.
UTHR in Licensing Agreement with Corsair Pharma: United Therapeutics (UTHR - Free Report) , a key player in the pulmonary arterial hypertension (“PAH”) market, announced an exclusive license agreement with Corsair Pharma for the latter’s portfolio of patents covering treprostinil prodrugs.
In addition to getting an upfront payment, Corsair will receive royalty payments on the commercialization of treprostinil prodrug products by United Therapeutics that are covered by Corsair's patents. The agreement terms also include an equity investment by United Therapeutics in Corsair.
Spark Provides Update on Luxturna: Spark Therapeutics has priced its one-time gene therapy treatment, Luxturna, at $850,000. However, the company also announced three new payer programs that are expected to lower the financial burden for patients as well as treatment centers. The company has been working with health insurers to ensure access to Luxturna (Read more: Spark Therapeutics Hopes to Cure a Rare Blindness for $850,000 a Pop).
Luxturna was approved in December 2017 for patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. According to the FDA, biallelic RPE65 mutation-associated retinal dystrophy affects approximately 1,000 to 2,000 patients in the United States.
Spark is a Zacks Rank #3 (Hold) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 3.1% over the last four trading sessions. Among major biotech stocks, Biogen (BIIB - Free Report) gained 6.2%. Over the last six months, Biogen was up 24.7% while Celgene lost 16.2% (See the last biotech stock roundup here: BIIB, CELG Hit by Pipeline News, Acquisition Deals for Ignyta, Sucampo).
What's Next in the Biotech World?
Watch out for updates and outlooks that will be provided by several companies next week at the 36th Annual J.P. Morgan Healthcare Conference.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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