When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments and of firms’ finances. Prioritizing comprises selecting as much as possible the most concrete subjects that are safe to explore.
In the upcoming Prohost Letter #400, we increased the number of news to be cited about biotech, biopharmaceutical and pharmaceutical companies, not just to give more options for selection, but to protect ourselves from the hype, which can cause us to abandon ships that could be the best vehicles capable of reaching their destinations.
From Today’s News, We Select the following:
A Strategic Collaboration
The strategic collaboration is between Ocular Therapeutix (OCUL), a biopharmaceutical company specialized in the development of therapies for eye diseases and conditions and Regeneron Pharmaceuticals (REGN).
The two firms decided to act together in development of a sustained release formulation of the vascular endothelial growth factor (VEGF) trap aflibercept currently approved by the U.S. Food and Drug Administration for wet age-related macular degeneration (wet AMD). The drug is a blockbuster that sells under the brand name EYLEA® for wet macular degeneration and for other serious eye diseases.
The sustained release formulation is already in preclinical development.
Ocular Therapeutix is currently developing proprietary sustained-release hydrogel-based drug delivery depots for intravitreal injection that can be formulated with both small and large molecules, such as tyrosine kinase inhibitors (TKIs) and protein-based anti-VEGFs, respectively, with the goal of delivering sustained and therapeutic levels of drugs to targeted ocular tissues.
Under the terms of the agreement: Ocular Therapeutix and Regeneron will aim to develop a sustained release formulation of aflibercept that is suitable for advancement into clinical development.
For Regeneron: Obtaining an exclusive license to use Ocular Therapeutix’s hydrogel-based technology for the development and commercialization of a sustained release formulation of aflibercept and other biologics targeting VEGF for ophthalmic indications.
For Ocular Therapeutix: Retaining all rights to develop its sustained-release hydrogel-based drug delivery platform with all other non-VEGF targeting compounds as well as with small molecule pharmaceuticals, including TKIs, for other retinal diseases.
Upon exercising of the option;
– Would receive a payment of $10 million from Regeneron and takes the responsibility for funding development through Phase 1.
– would be eligible to receive up to $305 million in milestone payments from Regeneron for a sustained release version of aflibercept containing Ocular Therapeutix’s sustained release hydrogel depot, comprised of up to $155 million in development and regulatory milestone payments, $100 million for the first commercial sale and up to $50 million in commercial milestone payments. In addition, Ocular Therapeutix is eligible to receive tiered high single-digit to low-to-mid teen-digit royalties on potential future net sales.
– Would be responsible for any subsequent development and commercialization costs.
Amar Sawhney, Ph.D., President, Chief Executive Officer and Chairman of Ocular Therapeutix said, “We have made considerable progress in developing our protein drug delivery platform at Ocular Therapeutix, so it is good to see an industry leader such as Regeneron recognizing the potential of this technology. We are excited to partner with Regeneron to develop a potential first-in-class sustained release protein-based anti-VEGF hydrogel injection for wet AMD, DME, RVO, and other serious retinal diseases. This sustained release formulation could have the potential to significantly reduce dosing frequency and subsequently reduce doctor visits, thus reducing the burden of care for patients, caregivers and physicians, and may decrease the likelihood of certain side effects associated with frequent intravitreal injections.”
Wet age-related macular degeneration (wet AMD) is caused by the degeneration of the central portion of the retina. Abnormal growth of blood vessels below the retina, and the leakage of fluid and protein from the vessels, causes retinal degeneration and can lead to severe and rapid loss of vision. Wet AMD is the leading cause of blindness in individuals aged 50 years or older.
Retinal vein occlusion (RVO) is a sight-threatening disorder resulting from the blockage of one of the veins carrying blood out of the retina. In RVO, the blockage of a retinal vein can lead to poor blood circulation, low oxygen and sometimes inflammation in the eye. A blocked vein will leak its contents of blood and fluid. Bleeding within the retina and swelling from the fluid can result in macular edema.
Diabetic macular edema (DME) is a complication of diabetes caused by fluid accumulation in the macula, or central portion of the eye. When the macula begins to fill with fluid, the ability of those cells to sense light is impaired, causing blurred vision that can be severe. Diabetic macular edema affects up to 30% of people who have had diabetes for 20 years or more, and if untreated, 20 to 30% of people who have it will experience moderate visual loss.
The global market for anti-VEGF drugs is over $7.5 billion. Regeneron’s drug EYLEA® is the leader in the race that led to the treatment of wet macular degeneration and the other eye diseases mentioned above
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team hosted a live conference call and webcast today at 8:30 am Eastern Time today to discuss the collaboration with Regeneron as well as other recent progress from the Company’s intravitreal depot development programs.
The live webcast and accompanying slide presentation can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com
An archive of the webcast will be available until October 27, 2016 on the Company’s website.
A successful outcome of the collaboration between Regeneron and Ocular Therapeutix will be
Great news for both collaborating firms and for Wet macular degeneration sufferers. We know what Regeneron is and how it grew from a tiny biotech firm into a large top-tier biotech elite. We take advantage of the news to visit with and learn about Ocular Therapeutix, Inc.
Ocular Therapeutix is publicly-traded biopharmaceutical firm on the NASDAQ stock exchange with the symbol OCUL. The firm uses its proprietary hydrogel platform technology in producing new therapies for diseases and conditions of the eye.
Ocular Therapeutix News and Pipeline:
ReSure® Sealant is FDA-approved to seal corneal incisions following cataract surgery.
DEXTENZA™ (dexamethasone insert, extended release): Is in Phase 3 clinical development for post-surgical ocular inflammation and pain and allergic conjunctivitis. The firm has submitted an NDA for DEXTENZA™ for the above indication. The product is also in Phase 2 clinical development for dry eye disease.
OTX-TP (sustained release travoprost) is in Phase 3 clinical trial for glaucoma and ocular hypertension.
Ocular Therapeutix is also evaluating sustained-release injectable drug depots for back-of-the-eye diseases.
For additional information about the Company, please visit www.ocutx.com.
Stock Price: $7.47 UP $1.15 today in the news.
52-week range: $4.04 – $17.34
Market Cap.: $185.55
Total Cash: $84 M
Total Dept: $15.46
Revenues: $1.7 M
Like all other development-stage firms, the firm is losing money. Important to notice, though, that the firm has filed NDA for the approval of its lead product Dextenza™.
All we can do is wait and see for a while and follow up on this firm that managed to attract Regeneron Pharmaceuticals to its drug delivery technology to be used on its best-selling product EyLea and, probably, other products.
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Today: EYE ON
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