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Biotech Stock Roundup: Pipeline Updates From VRTX & AMGN, ADRO Teams Up With LLY
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It was a busy week for the biotech sector with regular pipeline and regulatory updates. The key events include Aduro’s collaboration with Eli Lily and FDA approval for Amgen’s (AMGN - Free Report) label expansion of ITP drug.
Recap of the Week’s Top Stories:
Aduro Biotech Collaborates with Lilly: Aduro Biotech, Inc. announced a research collaboration and exclusive license agreement with pharma giant Eli Lilly LLY. The companies have entered into a license agreement for Aduro's cGAS-STING Pathway Inhibitor program for the research and development of novel immunotherapies for autoimmune and other inflammatory diseases. Per the agreement, Lilly will gain access to novel molecules from Aduro that are designed to inhibit the cGAS-STING pathway. Both the companies will advance these molecules, as well as others from Lilly, into clinical development. In exchange, Aduro will receive an upfront payment of $12 million and also be eligible for development and commercial milestones up to approximately $620 million per product and royalty payments in the single to low-double digits should Lilly successfully commercialize a therapy from the collaboration. Moreover, Aduro will obtain research funding during the research term. The company has the option to co-fund the clinical development of each product in exchange for an increase in royalty payments. Lilly will be responsible for all costs of global commercialization.
Vertex Announces Positive Data on Pipeline Candidate: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the mid-stage study on investigational NaV1.8 inhibitor VX-150 in patients with pain caused by small fiber neuropathy was successful. Data showed that treatment with VX-150 demonstrated statistically significant and clinically meaningful pain reduction, as measured by the within-group change from baseline in the weekly average of daily pain intensity on the 11-point numeric rating scale (NRS) at week 6. The study met its primary endpoint. The candidate provided significant relief from pain in patients with small fiber neuropathy and was generally well tolerated. Additionally, a phase IIb dose-ranging study of VX-150 following bunionectomy surgery is currently ongoing to support potential pivotal development. Moreover, Vertex is advancing multiple pain molecules through late-stage preclinical development. The first of these candidates is expected to enter the clinic in 2019.
Previously, the company announced that Health Canada has granted Market Authorization for cystic fibrosis (CF) drug, Orkambi, to include use in children ages 2 through 5 years who have two copies of the F508del CFTR mutation.
Evofem Gains on Positive Data on Birth Control Gel: Shares of Evofem Biosciences, Inc. surged after the company announced that its late stage trial AMPOWER on lead candidate Amphora for the prevention of pregnancy was successful. Amphora is a non-hormonal, on-demand, woman-controlled prescription birth control vaginal gel. The phase III study assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers. The primary endpoint of the study was the pregnancy rate over seven cycles of use (one cycle equals to 21-35 days) as assessed by the Kaplan-Meier statistical method. The data from the study showed a cumulative pregnancy rate of 14.0% over seven cycles of use, which corresponds to an efficacy rate of 86%. Consequently, the study met its primary endpoint. The efficacy went up to 98.7% with the cumulative pregnancy rate of 1.3% over seven cycles of use when Amphora was used as directed. The company plans to submit the New Drug Application to the FDA for Amphora in the second quarter of 2019 and analyse the data further. Assuming approval, the company will commercialize this first-in-class MVP-R for birth control in January 2020.
Incyte Collaborates With Innovent Biologics : Incyte (INCY - Free Report) announced that it has entered into a strategic collaboration agreement with China based Innovent Biologics, Inc. Both the companies have entered into an agreement, through their respective subsidiaries, for the development of three clinical-stage product candidates — pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Per the terms, Innovent will pay Incyte $40 million in cash up front. Additionally, Incyte is eligible to receive an additional $20 million in consideration in connection with the first investigational new drug (IND) application by Innovent in China (expected in 2019). In exchange, Innovent will receive the rights to develop and commercialize the three assets (pemigatinib, itacitinib and parsaclisib) in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Moreover, Incyte will be eligible to receive up to $129 million in potential development and regulatory milestones, and up to $202.5 million in milestone achievements. Further, Incyte is eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Moreover, Incyte retains an option to assist in the promotion of the three product candidates in China.
Amgen Gets Thrombocytopenia Drug Approval: Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for immune thrombocytopenia (ITP) drug Nplate. The drug is approved for the treatment of pediatric patients who are one year of age and older with immune thrombocytopenia (ITP) for at least six months and have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The drug is already approved for the treatment of adults. The company also submitted a Biologics License Application (BLA) to the FDA for ABP 710, a biosimilar version of Remicade.
The company also announced a strategic collaboration with Molecular Partners AG (MOLN). Both the companies entered into a license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). Per the terms, Amgen obtained exclusive global development and commercial rights for MP0310. MP0310 will be evaluated in combination with Amgen`s oncology pipeline products, including its investigational BiTE molecules. Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin pipeline products in combination with MP0310. The latter will also receive an upfront payment of $50 million and is eligible to receive up to $497 million in development, regulatory and commercial milestone payments, and double-digit, tiered royalties up to the high teens.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 5.69% in the last five trading sessions. Among the major biotech stocks, Alexion lost 7.7%. Over the past six months, shares of Regeneron have rallied 16.92%, while Celgene has dropped 14.28%. (See the last biotech stock roundup here: Biotech Stock Roundup: Gilead to Get New CEO, Biogen In-Licenses Candidate)
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
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: Pipeline Updates From VRTX & AMGN, ADRO Teams Up With LLY
It was a busy week for the biotech sector with regular pipeline and regulatory updates. The key events include Aduro’s collaboration with Eli Lily and FDA approval for Amgen’s (AMGN - Free Report) label expansion of ITP drug.
Recap of the Week’s Top Stories:
Aduro Biotech Collaborates with Lilly: Aduro Biotech, Inc. announced a research collaboration and exclusive license agreement with pharma giant Eli Lilly LLY. The companies have entered into a license agreement for Aduro's cGAS-STING Pathway Inhibitor program for the research and development of novel immunotherapies for autoimmune and other inflammatory diseases. Per the agreement, Lilly will gain access to novel molecules from Aduro that are designed to inhibit the cGAS-STING pathway. Both the companies will advance these molecules, as well as others from Lilly, into clinical development. In exchange, Aduro will receive an upfront payment of $12 million and also be eligible for development and commercial milestones up to approximately $620 million per product and royalty payments in the single to low-double digits should Lilly successfully commercialize a therapy from the collaboration. Moreover, Aduro will obtain research funding during the research term. The company has the option to co-fund the clinical development of each product in exchange for an increase in royalty payments. Lilly will be responsible for all costs of global commercialization.
Aduro carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Announces Positive Data on Pipeline Candidate: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the mid-stage study on investigational NaV1.8 inhibitor VX-150 in patients with pain caused by small fiber neuropathy was successful. Data showed that treatment with VX-150 demonstrated statistically significant and clinically meaningful pain reduction, as measured by the within-group change from baseline in the weekly average of daily pain intensity on the 11-point numeric rating scale (NRS) at week 6. The study met its primary endpoint. The candidate provided significant relief from pain in patients with small fiber neuropathy and was generally well tolerated. Additionally, a phase IIb dose-ranging study of VX-150 following bunionectomy surgery is currently ongoing to support potential pivotal development. Moreover, Vertex is advancing multiple pain molecules through late-stage preclinical development. The first of these candidates is expected to enter the clinic in 2019.
Previously, the company announced that Health Canada has granted Market Authorization for cystic fibrosis (CF) drug, Orkambi, to include use in children ages 2 through 5 years who have two copies of the F508del CFTR mutation.
Evofem Gains on Positive Data on Birth Control Gel: Shares of Evofem Biosciences, Inc. surged after the company announced that its late stage trial AMPOWER on lead candidate Amphora for the prevention of pregnancy was successful. Amphora is a non-hormonal, on-demand, woman-controlled prescription birth control vaginal gel. The phase III study assessed the efficacy, safety and subject satisfaction with Amphora in approximately 1,400 healthy women aged 18-35 years at 112 centers. The primary endpoint of the study was the pregnancy rate over seven cycles of use (one cycle equals to 21-35 days) as assessed by the Kaplan-Meier statistical method. The data from the study showed a cumulative pregnancy rate of 14.0% over seven cycles of use, which corresponds to an efficacy rate of 86%. Consequently, the study met its primary endpoint. The efficacy went up to 98.7% with the cumulative pregnancy rate of 1.3% over seven cycles of use when Amphora was used as directed. The company plans to submit the New Drug Application to the FDA for Amphora in the second quarter of 2019 and analyse the data further. Assuming approval, the company will commercialize this first-in-class MVP-R for birth control in January 2020.
Incyte Collaborates With Innovent Biologics : Incyte (INCY - Free Report) announced that it has entered into a strategic collaboration agreement with China based Innovent Biologics, Inc. Both the companies have entered into an agreement, through their respective subsidiaries, for the development of three clinical-stage product candidates — pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor). Per the terms, Innovent will pay Incyte $40 million in cash up front. Additionally, Incyte is eligible to receive an additional $20 million in consideration in connection with the first investigational new drug (IND) application by Innovent in China (expected in 2019). In exchange, Innovent will receive the rights to develop and commercialize the three assets (pemigatinib, itacitinib and parsaclisib) in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Moreover, Incyte will be eligible to receive up to $129 million in potential development and regulatory milestones, and up to $202.5 million in milestone achievements. Further, Incyte is eligible to receive tiered royalties from the high teens to the low twenties on future sales of products resulting from the collaboration. Moreover, Incyte retains an option to assist in the promotion of the three product candidates in China.
Amgen Gets Thrombocytopenia Drug Approval: Amgen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for immune thrombocytopenia (ITP) drug Nplate. The drug is approved for the treatment of pediatric patients who are one year of age and older with immune thrombocytopenia (ITP) for at least six months and have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The drug is already approved for the treatment of adults. The company also submitted a Biologics License Application (BLA) to the FDA for ABP 710, a biosimilar version of Remicade.
The company also announced a strategic collaboration with Molecular Partners AG (MOLN). Both the companies entered into a license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). Per the terms, Amgen obtained exclusive global development and commercial rights for MP0310. MP0310 will be evaluated in combination with Amgen`s oncology pipeline products, including its investigational BiTE molecules. Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin pipeline products in combination with MP0310. The latter will also receive an upfront payment of $50 million and is eligible to receive up to $497 million in development, regulatory and commercial milestone payments, and double-digit, tiered royalties up to the high teens.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 5.69% in the last five trading sessions. Among the major biotech stocks, Alexion lost 7.7%. Over the past six months, shares of Regeneron have rallied 16.92%, while Celgene has dropped 14.28%. (See the last biotech stock roundup here: Biotech Stock Roundup: Gilead to Get New CEO, Biogen In-Licenses Candidate)
What's Next in Biotech?
Stay tuned for more regulatory and pipeline updates.
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.
Click for details >>