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Dr. Reddy’s Laboratories Ltd announced the launch of over-the-counter (OTC) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1% are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. The Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is also indicated for the temporary relief of red eyes.

“This launch marks the entry of Dr. Reddy’s into the OTC eye care space, and is a testament to our deep capabilities in bringing store-brand equivalents of Rx-to-OTC switches to the U.S. market,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “We are very excited to extend our strategic collaboration with Gland Pharma to bring these products to the market. We thank the teams at Gland and Dr. Reddy’s whose hard work and efforts have enabled the execution of this launch in such a short timeframe.”

The Pataday® brand had U.S. sales of approximately $31 million since the launch in March 2020 according to IRi*.

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is available in a 2.5 mL bottle and Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is available in a 5 mL bottle size.

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate. 

"We are excited about the potential of helping patients with AL amyloidosis who currently have no FDA-approved therapies for the treatment of their disease," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "The results from the Phase 3 ANDROMEDA study also provide preliminary evidence of DARZALEX FASPRO's potential to modify the organ damage that is a hallmark of this serious disease with high unmet needs and we look forward to collaborating with the agency in the review of the application."

The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.

The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.

AL amyloidosis is a life-threatening disorder that occurs when plasma cells in the bone marrow produce abnormal light chains, that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, GI tract and nervous system. Diagnosis of AL amyloidosis is often delayed because patients present with non-specific symptoms that mimic other conditions, resulting in a poor prognosis. There are currently no FDA-approved therapies to treat this devastating disease. While AL amyloidosis is the most common type of amyloidosis, it remains a rare disease with an estimated 30,000 to 45,000 people living with the disease in the U.S. and Europe. Each year, an estimated 4,500 people develop AL amyloidosis in the U.S. alone.

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Strides Pharma Science Limited (Strides) stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.

As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc. 

Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years.

As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year.

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Baxter International Inc a global innovator in renal care, announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for Theranova, the company’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.

By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space. In fact, less than 1% of devices granted marketing authorization under De Novo have been for the care of patients with kidney failure since the pathway’s inception in 1997.

HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment2,3. This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney.

"U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova," said Gavin Campbell, general manager of Baxter's U.S. Renal Care business. "Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure healthcare providers can also realize the full value of this therapy for their patients on HD."

To date, over 90 independent and Baxter-led or sponsored studies have been conducted on HDx therapy enabled by Theranova. The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.

"Individually, the side effects from standard HD, which patients typically undertake three days a week, four hours per day, may seem manageable. However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy," explained Mary Gellens, M.D., nephrologist and senior medical director at Baxter. "HDx therapy enabled by Theranova is a promising alternative to what is currently available because it delivers a filtration profile that is closer to the natural kidney."

Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in the United States that evaluated the safety and efficacy of HDx therapy enabled by Theranova. During the study, as reported during the 2019 American Society of Nephrology Kidney Week, 172 hemodialysis patients received therapy with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (ELISIO-17H) over 24 weeks of treatment, with a primary efficacy endpoint measuring the reduction ratio of lambda (λ) free light chains at 24 weeks of treatment, while maintaining pre-dialysis serum albumin levels. Data from the study, which was just published in the Clinical Journal of the American Society of Nephrology (CJASN), found that expanded hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of large middle molecules, as exemplified by λ free light chains, as compared to a similarly sized high flux dialyzer while maintaining serum albumin levels7. Large middle molecules are a diverse group of uremic toxins that are believed to contribute to the high cardiovascular disease burden in end stage kidney disease8. Dialysis technologies available to date offer limited clearance of these molecules8. The ability to efficiently remove these large middle molecules provides dialysis patients with a new alternative therapy.

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The Russian President Vladimir Putin has launched a coronavirus vaccine amid the global race to develop and distribute it. The world’s first vaccine comes even with the final stages of clinical trials to test efficiency and safety still going on.

The announcement came in the wake of the Covid-19 pandemic that has infected more than 20 million people and killed around 0.75 million people all over the world. It has also resulted in crippling world economies.

The Russian vaccine has been developed by the Gamaleya Institute in Moscow. The vaccine uses two strains of adenovirus that is known to cause mild cold in humans. Adenovirus vaccine is under trial in many other countries as well. The strains are genetically modified which can cause infected cells to create proteins from the spike of the coronavirus. This is a similar approach to a vaccine under development by AstraZeneca and Oxford University.

As per reports, Russia has dubbed the newly created vaccine “Sputnik V” after its Soviet satellite. Kirill Dmitriev, who is the head of the Russian Direct Investment Fund, an organization responsible for financing the vaccine project, announced that the Phase 3 trials would start by Wednesday. This means that mass production can be expected from September. He also mentioned that around 20 countries have already pre-ordered more than a billion doses.

Putin thanked everyone who has worked on the vaccine’s development and mentioned that this is a very important step for the world. He also hopes that the country’s research body should start the mass production of the vaccine very soon.

When talking about the vaccine, Putin mentions that it works effectively, helps build strong immunity, and has passed all the needed checks. He also added that one of his two daughters have received a shot of the vaccine and is doing well.

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Roche announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS). The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS.’’

The approval is based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRRs) for a two-hour OCREVUS infusion time vs. the conventional 3.5-hour time in patients with relapsing-remitting MS (RRMS) (289 patients shorter infusion; 291 conventional infusion). The first dose was administered per the approved dosing schedule (two 300 mg intravenous (IV) infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time.

The primary endpoint of this study was the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%). The majority of IRRs were mild or moderate, and more than 98% resolved in both groups without complication. No IRRs were life-threatening, serious or fatal. No patients discontinued the study due to an IRR and no new safety signals were detected.

As previously communicated, the U.S. Food and Drug Administration accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by 14 December 2020.

With rapidly growing real-world experience and more than 160,000 patients treated globally, OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and primary progressive MS (PPMS). OCREVUS is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

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AMAG Pharmaceuticals, Inc announced it has completed the sale of its rights to Intrarosa (prasterone) to Millicent Pharma Limited, a global pharmaceutical company formed by the Millicent Pharma management team and The Carlyle Group in 2018 that specializes in womens health and menopause-related conditions, for up to USD 125 million, including upfront fixed consideration of USD 20 million and contingent, sales-based milestone payments of up to USD105 million.

"As mentioned in our first quarter earnings release, the sale of Intrarosa is an important step in our strategic evolution,” said Scott Myers AMAG’s president and chief executive officer. “We were impressed with Millicent’s commercial capabilities and dedication to women’s healthcare and we are pleased to transition this important therapy into their portfolio. We remain focused on maximizing Feraheme’s value, maintaining patient access to Makena and developing innovative therapies, while managing expenses to help further our goal of achieving profitability in 2020.”

In addition to the upfront consideration of USD 20 million, AMAG will be entitled to certain sales milestone payments, which include USD 25 million the first time Intrarosa net sales exceed USD 65 million during any consecutive 12-month period, a second sales milestone payment of USD 35 million the first time Intrarosa net sales exceed USD 115 million during any consecutive 12-month period, and a third milestone payment of USD 45 million the first time Intrarosa net sales exceed SUD 175 million during any consecutive 12-month period.

The sale of Intrarosa is consistent with AMAG’s previously announced strategic decision to divest its women’s health assets. AMAG has agreed to provide certain transitional services to Millicent Pharma for a limited period of time while Intrarosa is operationally separated from AMAG. AMAG remains committed to the divestiture of Vyleesi and associated expense reductions as previously announced.

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Asia’s premier biopharmaceuticals company, announced today that its subsidiary Biocon Biologics India Ltd. has received the Certificate of GMP compliance from EMA for multiple Biologics Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Biocon Park, Bengaluru.

These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets, and were inspected in March 2020.

This approval expands Biocon Biologics’ capacities multi-fold to address the growing needs of patients in the EU markets for Trastuzumab commercialized in March 2019 and for Pegfilgrastim expected to be commercialized soon. This certification would further enable the approval process of our biosimilar Bevacizumab, the Marketing Authorization Application for which is currently under review by the European authorities.

Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics India Ltd, said, “We are extremely pleased with the EU GMP certification for our Biologics DP and DS manufacturing facilities in Bengaluru. This approval will support the penetration of Trastuzumab and Pegfilgrastim in Europe. This certification is expected to further enable the approval of biosimilar Bevacizumab in the EU. We remain committed to enhance access to our high quality biosimilars and global standards of quality and compliance and reaching the milestone of USD 1 billion in revenues in FY22. ”

Biocon Biologics has been making continued investments in building global scale, cost-competitive, complex manufacturing capabilities to address market opportunities worldwide. We expanded our production capacity for Pegfilgrastim Drug Substance through the new B-4 manufacturing facility in Bengaluru, which received U.S. FDA approval in November 2019 and started commercial operations subsequently. In 2019, we also expanded production capacity for our biosimilar Trastuzumab through a new Drug Product (DP) filling line at the B-2 biologics facility, which received U.S. FDA approval in October 2019.

Biocon Biologics, through its partner Mylan, has commercialized two of its co-developed biosimilars, Trastuzumab and Insulin Glargine, in EU. The commercialization of biosimilar Pegfilgrastim in the EU is imminent. These approvals further strengthen our ability to bring products to patients in EU. Going forward, through our strong portfolio of in-market and in-review biosimilars we will pursue the path of growth in EU, where the market for biosimilars is sizable and growing.

Biocon Biologics is committed to serve the needs of patients, people and partners by providing innovative affordable healthcare solutions going beyond the product. It aims to impact 5 million patient lives and cross a revenue milestone of USD 1 billion in FY22 .

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