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(Reuters) – Syneos Health Inc (SYNH.O), a U.S. contract research organization (CRO) that serves the pharmaceutical industry, is exploring a sale, people familiar with the matter said on Monday.

A deal for Syneos would be the latest in string of acquisitions of CROs, which have benefited in recent years from pharmaceutical companies’ drive to cut costs, reduce clinical trial times and expand their research and development presence around the world.

Syneos is working with investment bank Centerview Partners on soliciting acquisition offers from other companies and private equity firms, the sources said.

The sources cautioned that a deal is not certain and asked not to be identified because the matter is confidential. Syneos declined to comment, while Centerview did not respond to a request for comment.

Syneos shares were trading down 30% because of the stock market rout before the Reuters story on Monday, but jumped on the news of the possible sale to trade up 1.7% at $65.60, giving it a market value of close to $7 billion. Syneos also had a debt pile of $2.7 billion as of the end of December.

Shionogi has expanded its partnership with its Alzheimer’s drug development partner Tetra Therapeutics, giving an option for a buyout of the US biotech ahead of a key trial milestone.

The two companies will work together to develop and market BPN14770 for Alzheimer’s disease, Fragile X syndrome and other indications marked by cognitive and memory deficits.

Shionogi has increased its equity investment in Tetra to 50% and has the option to complete a structured buyout of the remaining equity if certain conditions are met.

The option hinges on results of the phase 2 PICASSO AD trial in patients with early Alzheimer’s disease expected to read out later this month.

Shionogi’s move comes at a time when there are major question marks about the treatment approaches from mainstream pharma companies for Alzheimer’s, which have mainly focused on the amyloid plaques that build up in those affected by the disease.

After a string of trial failures, the so-called “amyloid hypothesis” will likely receive its definitive test soon when Biogen files results of two phase 3 trials with the FDA in the coming weeks or months.

Although these trials also failed Biogen thinks it has the data to show the drug aducanumab is effective at higher doses.

While Biogen tries to revive aducanumab pharma companies and biotechs are looking for alternatives.

Tetra’s BPN14770 selectively inhibits phosphodiesterase-4D (PDE4D) to enhance memory formation in children and older adults.

Tetra is developing BPN14770 for brain disorders marked by cognitive and memory impairment including Alzheimer’s disease and Fragile X syndrome.

Michigan-based Tetra has completed enrolment in a phase 2 study of BPN14770 in adults with Fragile X syndrome, an indication for which BPN14770 has received Orphan Drug Designation from the FDA.

Tetra says the mechanism of action could improve cognitive and memory function in devastating CNS disorders, including Fragile X syndrome, Alzheimer’s disease and other dementias, learning/developmental disabilities and schizophrenia.

Preclinical animal models show that BPN14770 may promote the maturation of connections between neurons, which is impaired in patients with Fragile X Syndrome, and to protect connections between neurons which otherwise are lost in patients with Alzheimer’s disease.

Tetra has completed phase 1 double blind, placebo-controlled, dose-ranging studies of the safety and pharmacokinetics of BPN14770 in healthy volunteers.

The company said evidence of cognitive benefit was found in elderly subjects.

EyePoint Pharmaceuticals, based in Watertown, Massachusetts, announcedpositive topline 36-month follow-up data from the second Phase III trial of Yutiq (fluocinolone acetonide intravitreal implant) for treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Yutiq was approved by the U.S. Food and Drug Administration (FDA) on October 12, 2018 for this indication. Non-infectious posterior segment uveitis is an inflammatory disease affecting the rear section of the eye, often involving the retina. It affects all ages and results in swelling that destroys eye tissues, which can lead to severe vision loss and blindness. It affects between 55,000 and 120,000 people in the U.S., causing about 30,000 cases of blindness.

“The durable 36-month follow-up data from the second Phase III trial of Yutiq highlight its long-term ability to reduce uveitic flares, consistent with the findings from the first Phase III trial,” said Thomas Albini, Professor of Clinical Ophthalmology at Bascom Palmer Eye Institute in Miami, Florida.

Albini went on to say, “Reduction of uveitic flares is a key component in the treatment of this devastating disease leading to progressive vision loss and blindness, thus the recurrence rate of 46.5% at 36-months is compelling.”

There were no unanticipated side effects at the 12, 24 and 36-month periods. The efficacy and safety data, as well as the fact it is a one-time dosing drug, should position the drug as a good alternative to standard treatment, which is typically local steroid injections or systemic steroids, which have limited duration of effect and can develop serious side effects. Once that happens, patients are usually shifted to systemic immune suppressants or biologics, which have severe side effects including increased risk of cancer.

The company recently made several deals. On February 18, EyePoint entered into a purchase agreement with Vision Center Network of America for Dexycu (dexamethasone intraocular suspension) for Vision Center’s network of nine surgery centers in New York and New Jersey. This will allow VCNA doctors to use Dexycu in their surgical protocols for ocular inflammation associated with cataract surgery.

On February 3, EyePoint signed an exclusive license deal with Equinox Science to develop vorolanib, a tyrosine kinase inhibitor for wet age-related macular degeneration (wAMD), diabetic retinopathy (DR) and retinal vein occlusion (RVO). Voralanib is being developed as EYP-1901 using EyePoint’s bioerodible Durasert technology, a miniaturized, injectable, sustained-release intravitreal drug delivery system with a six-month duration.

Under the deal, EyePoint paid Equinox $1 million and will pay developmental and regulatory milestones and post-commercialization royalties.

Of today’s announcement, Nancy Lurker, president and chief executive officer of EyePoint said, “We continue to believe Yutiq is a differentiated treatment option compared to existing therapies because of its highly efficacious and solid safety profile, coupled with its convenient, single administration and long-term consistent dosing of drug. The 36-month results provide additional support in its long-acting potential, a characteristic consistently regarded by treating physicians as a critical treatment advantage. Our commercial efforts are yielding increased reception and adoption from uveitis specialists across the U.S., as well as positive patient feedback on the Yutiq product profile.”

Shares of Karyopharm Therapeutics soared Monday after the company posted positive Phase III results in multiple myeloma and announced it is planning a regulatory submission in the second quarter of this year for its combination of Xpovio, Velcade and Dexamethasone.

Newton, Mass.-based Karyopharm said the once-per-week triple combination of Xpovio (selinexor), Takeda’s Velcade (bortezomib) and low-dose Dexamethasone significantly increase progression-free survival (PFS) results in comparison to standard twice-weekly Velcade plus low-dose dexamethasone in patients with multiple myeloma who have received one to three prior lines of therapy. Karyopharm noted its once-per-week therapy yielded a 47% increase in median PFS in comparison to the standard-of-care treatment. The median PFS in the triple-combination arm was 13.93 months compared to 9.46 months in the standard-of-care arm, representing a 4.47-month increase in median PFS. 

Karyopharm said it will present full top-line data from the Phase III BOSTON study at an upcoming medical conference. The company noted there were no new safety signals and no imbalance in deaths between the two study arms.

Sharon Shacham, president and chief scientific officer at Karyopharm, said the BOSTON study is the first randomized Phase III trial to demonstrate clinically and statistically significant activity of once-weekly Xpovio in combination with a current standard of care treatment in patients with myeloma after one to three prior therapies. Pointing to the 47% PFS data, Shacham said the company believes this represents “an important improvement in the treatment of patients with relapsed or refractory multiple myeloma.”

“We plan to submit the full data set for presentations at upcoming medical meetings to share the results with the medical community. We also intend to submit these data as quickly as possible to the U.S. Food and Drug Administration (FDA) as part of a supplemental New Drug Application seeking to expand the approved indication for Xpovio into second-line treatment for patients with relapsed or refractory multiple myeloma,” she said in a statement.

 If approved, the triple-combination therapy would be the first and only FDA-approved combination drug regimen that includes once-weekly Velcade therapy for relapsed myeloma, Shacham added.

Karyopharm’s Xpovio is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Xpovio was initially greenlit by the FDA last year in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody. The approval process had something of a rocky road after FDA briefing materials for an advisory committee meeting raised concerns over the drug’s safety profile. Karyopharm submitted additional data it had and the drug was approved.

 Multiple myeloma is the second most common blood cancer in the U.S. with more than 32,000 new cases each year and over 130,000 patients living with the disease. Despite recent therapeutic advances, there is currently no cure and most patients’ disease will typically progress following treatment with currently available therapies.

Karyopharm is also anticipating additional indications for Xpovio. A supplemental New Drug Application was recently submitted to the FDA seeking accelerated approval for Xpovio as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Xpovio has received Fast Track and Orphan designation from the FDA for this patient population.

CRANBURY, N.J. and PHILADELPHIA, March 05, 2020 (GLOBE NEWSWIRE) — Amicus Therapeutics, Inc. (Nasdaq: FOLD) today announced the official opening of the company’s Global Research and Gene Therapy Center of Excellence in uCity Square in Philadelphia to advance its industry leading portfolio of rare disease gene therapy programs. In 2019, Amicus and the University of Pennsylvania (Penn) announced a major expansion of their Gene Therapy Collaboration which provides Amicus with disease-specific worldwide rights to Penn’s Next Generation Gene Therapy Technologies from the Wilson Lab for the majority of lysosomal storage disorders, as well as twelve additional more prevalent rare diseases including Rett Syndrome, Angelman Syndrome and select other muscular dystrophies.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “This is a remarkable advancement in the history of Amicus and further strengthens our great collaboration with Dr. Jim Wilson and the Gene Therapy Center at Penn. Philadelphia is a magnet for talent in gene therapy and an engine for innovation. This new global research center located in the ‘cradle of liberty’ will become part of the ‘cradle of cures’ as we move many gene therapy programs forward toward patients in need. With exclusive global rights to 50 rare diseases in collaboration with Dr. Wilson’s team we hope to be able to alleviate an enormous amount of human suffering with the great science work that will be done in this new facility.”

The 75,000 sq. ft. Center is located on the top three floors of the new building at 3675 Market Street and consists of office and state-of-the-art laboratories. It will ultimately house approximately 200 researchers and drug developers focused exclusively on gene therapies. 

A by invitation only ribbon cutting event takes place today to celebrate the opening with special guests to include Dr. Jim Wilson, government officials and patients living with rare diseases and their families.

About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases. For more information please visit the company’s website at www.amicusrx.com and follow on Twitter and LinkedIn.

Massachusetts-based Orionis Biosciences has flown under the radar since its founding in 2015, has leaped into the mainstream this morning with a major four-year drug discovery collaboration with Swiss pharma giant Novartis.

The two companies forged a collaboration to discover and design novel small molecule therapeutics, such as protein degraders, across various therapeutic areas. Novartis will leverage Orionis’ Allo-Glue technology platform. The molecules in the Allo-Glue platform enable access to targets previously thought unapproachable, the company said. The molecules in the platform are a unique class of allosterically acting small molecules, Orionis noted.

“They act to alter the form and function of, and thereby reprogram, intracellular proteins to engage in molecular interactions that modulate disease target proteins, including promoting their degradation by a cell’s natural protein disposal machinery,” said Orionis, which also has a site in Belgium.

Financial terms of the collaboration were not disclosed, but Orionis said the terms include research funding, a convertible note investment, royalties and potential clinical milestones.

Nike Kley, founder and chief executive officer of Orionis, which was named for the Orion star system, said the collaboration with Novartis “provides tremendous validation of the work we have accomplished over the past several years to develop innovative tools to unlock challenging drug targets for new therapeutic modalities.” Kley said there are numerous disease-related targets that so far have eluded researchers and drug developers for years.

“Our proprietary genome-wide discovery and drug design technologies may enable identification and development of small molecules and biologics with high specificity and selectivity against targets at a scale, speed and efficiency that is unique in the industry,” Kley said in a statement.

According to Orionis data, the company’s pipeline is designed to target multiple phases of the Cancer Immunity Cycle (CIC) to promote immune system-mediated clearance of and immunity to cancer. The company notes that its approach to tackling disease involves the “removal of various cancer-imposed brakes on components of the immune system, as well as targeted activation of and enhancement of infiltration of tumors by cancer-inhibitory immune cells, such as cytotoxic T cells (CTLs).” The company said its ultimate goal is the introduction of lasting memory T-cell responses to promote cancer immunity.

Jay Bradner, president of the Novartis Institutes for BioMedical Research, expressed the excitement about the working relationship with Orionis. Bradner said their hope is that through the collaboration with Orionis, Novartis will be able to “reach historically elusive targets” as they look to bring new therapeutic options to patients. Bradner said Novartis will combine its expertise in drug discovery and development with Orionis’ “innovative technologies for rapidly identifying and prioritizing new targets at a genome-wide scale.”

In addition to Kley at the helm of the company, Orionis is also led by Chief Technology Officer Jan Tavernier, who is also a professor at VIB-Ghent University in Belgium, as well as Riccardo Sabatini, who heads up the company’s computational science platform.

Sabatini said that it is exciting to see how the mapping of genome-scale fingerprints of drug action has opened new possibilities to support drug design.

Gilead Sciences, based in Foster City, California, announced it will launch two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19, the disease caused by the novel coronavirus.

The outbreak began in China in December and has since spread through much of the rest of the world, with most cases concentrated in Asia. The current number of confirmed cases worldwide is greater than 81,400 with a total death count of 2,770. The first cases of community spread of the virus—meaning not by someone who visited Asia recently—in the U.S. was reported yesterday.

Gilead’s trials will evaluate two dosing durations of the drug, which is given intravenously. The randomized, open-label, multicenter studies will enroll about 1,000 patients mostly in Asia, as well as in countries that have had high numbers of diagnosed cases. The trials are planned to start in March.

These trials are on top of two clinical trials in China’s Hubei province led by the China-Japan Friendship Hospital and a recently launched trial in the U.S. led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead donated the drug and provided scientific expertise for those trials. The China trial data is expected in April.

“Gilead’s primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug’s profile in a short amount of time,” said Merdad Parsey, Gilead’s chief medical officer. “The speed with which remdesivir has moved into clinical development for this coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the highest urgency.”

Remdesivir is a nucleotide analog with broad-spectrum antiviral activity in in vitro studies and in in vivo studies in animals against Ebola, Marburg, MERS and SARS. MERS and SARS are both caused by coronaviruses that have at least some similarities to the coronavirus causing COVID-19.

These two trials will study the safety and efficacy of a five-day and a 10-day dosing regimen of remdesivir in patients with severe COVID-19. About 400 patients will be randomized 1:1 to receive remdesivir 200 mg on the first day, followed by 100 mg each day until day 5 or 10 as well as standard of care.

The second study will look at the safety and efficacy of a five-day and 10-day dosing strategy compared to standard of care. About 600 patients will be randomized 1:1:1 to receive 200 mg remdesivir on the first day followed by 100 mg with standard of care each day until day 5 or 10, compared to standard of care alone.

It should be emphasized how unusually fast the launch of these trials is, which underlines the urgency of the coronavirus epidemic. Gilead initially announced it was considering remdesivir for COVID-19 in late January. It was originally developed to treat Ebola but has shown some success in targeting coronaviruses.

Yesterday, the Trump Administration announced that Vice President Mike Pence will head the U.S. efforts to control the coronavirus outbreak. This was met bycriticism, given Pence’s lack of medical credentials and what many view as a lack of success in handling HIV outbreaks when he was the governor of Indiana.

Another controversial that arose, besides mixed messages from public health authorities and President Trump, was a question yesterday to Health and Human Services Secretary Alex Azar on whether a coronavirus vaccine would be affordable. Azar’s answer was, essentially, no, they couldn’t guarantee it because of private sector involvement.

“We would want to ensure that we work to make it affordable, but we can’t control that price because we need the private sector to invest,” Azar told Congress. “Price controls won’t get us there.”

Although vaccines are currently being developed, including one by Moderna, widespread use of a vaccine would likely be at least a year away. Many experts in the field believe that drugs that are already in development, such as remdesivir, will likely be a more effective, faster options for dealing with the outbreak.

“The development of a vaccine is not going to prevent a pandemic here,” said Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, at the SVB Leerink Global Healthcare Conference.

He added, reports STAT, “I do have to be honest that for the vaccines, the idea that there’s going to be a vaccine that will really be able to be used in a large patient population and a large clinical trial, in the very near future, as in the next few months, I think that’s just not likely.”

Allecra Therapeutics, with locations in Saint-Louis, France and Weil, Am Rhein, Germany, indicated its Exblifep (cefepime-enmetazobactam) hit pre-specified primary endpoints in its Phase III ALLIUM clinical trial in complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). It also demonstrated superiority over piperacillin-tazobactam.

Exblifep is a combination of a novel extended-spectrum beta-lactamase inhibitor, enmetazobactam, and the fourth-generation cephalosporin cefepime. The drug has been ranted Qualified Infectious Disease Product and Fast Track Designation by the U.S. Food and Drug Administration (FDA), which gives it an additional five years market exclusivity and priority review.

The European Medicines Agency (EMA) reported that Allecra can seek approval of the drug for use in pneumonia, including HAP/VAP without running a Phase III trial for that indication because of it has already been approved in combination with cefepime and because of the results of the Epithelial Lining Fluid penetration study data with cefepime-enmetazobactam combination.

“Infections from ESBL-producing Enterobactericeae have increased in the US since 2000 and now also cause infection in the community,” said Keith Kayte, professor of Medicine and director of Research for Infectious Diseases at the University of Michigan. “According to most recent U.S. Center for Disease Control and Prevention (CDC) data, 197,400 cases of ESBL-producing Enterobacteriaceae occur every year with 9,100 associated deaths. The use of piperacillin-tazobactam for the treatment of such infections has been controversial, and the development of new treatments for these infections has been classified as a critical priority by the World Health Organization (WHO). Cefepime-enmetazobactam combination may provide a novel therapeutic option addressing this serious threat.”

The ALLIUM trial evaluated 1,034 patients who received either cefepime 2 g/enmetazobactam 0.5 g or piperacillin 4 g/tazobactam 0.5 g every eight hours as a two-hour continuous intravenous infusion. It was conducted at 112 sites in 19 countries. The primary efficacy endpoint was the composite success outcome of clinical cure and microbiological eradication at the test-of-cure visit.

Overall success was 79.1% for patients receiving Exblifep compared to 58.9% of piperacillin-tazobactam. Patients who stopped taking the drugs were comparable, with 5.2% in the Exblifep cohort and 4.0% in the piperacillin-tazobactam cohort. Exblifep was well tolerated, with 4.3% of patients reporting serious adverse events compared to 3.7% in the piperacillin-tazobactam group.

“The superiority demonstrated in the primary endpoint, at test of cure, combined with a comparable safety profile to that of well tolerated and widely used piperacillin-tazobactam support the potential use of cefepime-enmetazobactam as a new empiric and carbapenem-sparing treatment for multi-drug resistant Gram-negative infections,” said Patrick Velicitat, chief medical officer of Allecra.

In the U.S. there about 3.6 million patients with cUTIs that require antibiotic therapy. cUTIs, including acute pyelonephritis, are urinary tract infections ascending from the bladder along with local and systemic signs and symptoms, which include fever, chills, malaise, flank pain, back pain, and/or cost-vertebral angle pain or tenderness. These appear in the presence of a functional or anatomic abnormality of the urinary tract or during catheterization. Treatment is typically IV therapy in a hospital setting.

Acute pyelonephritis is a bacterial infection that inflames the kidneys and is one of the most common diseases of the kidney. It is a complication of an ascending UTI that spreads from the bladder to the kidneys. It is diagnosed in the U.S. at a rate of 15 to 17 cases per 10,000 females and three to four cases per 10,000 males each year.

China’s BrightGene Bio-Medical Technology has been censured by the Shanghai Stock Exchange for wrongly claiming it is able to manufacture Gilead’s experimental drug remdesivir – scientists’ best hope of a treatment for the novel coronavirus.

Shares in BrightGene tanked after the announcement from the stock exchange that the biotech has not gained approval from China’s drug regulator to make remdesivir.

BrightGene has not been licensed by Gilead, which owns the drug’s patent, to make the drug and it has not received clearance to mass produce it.

The announcement wiped 20% off the company’s share price in intraday trading, the daily limit of the stock exchange.

Remdesivir is an antiviral drug that is not approved to treat any disease, although it has shown promise in preclinical trials and late-stage trials have just begun against the coronavirus that causes the disease known as COVID-19.

It is being tested in hospitals in Wuhan, the centre of the coronavirus outbreak, as well as in the US.

BrightGene said on February 12th that it had managed to manufacture remdesivir in large quantities, sending its stock up 60% to a record high.

In a separate development, US biotech Moderna said it had shipped its first vaccine against coronavirus ready for a phase 1 study.

Vials of the vaccine dubbed mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned US-based study.

Moderna’s vaccine is mRNA-based and targets the spike (S) protein necessary for membrane fusion and host cell infection.

This protein has been the target of vaccines against the related coronaviruses that cause Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).

Moderna is one of several companies working on vaccines, including the US drugs giant Johnson & Johnson and its Janssen pharmaceuticals unit, as well as Sanofi and GlaxoSmithKline.

Boehringer Ingelheim has moved a step closer to getting approval for its blockbuster respiratory drug Ofev as the first treatment in the EU for a rare, life-threatening fibrotic disease.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Ofev (nintedanib) for the treatment of adults with interstitial lung disease caused by systemic sclerosis (SSc-ILD), an autoimmune disease – also known as scleroderma – which causes scarring (fibrosis) of multiple organs.

Ofev – which was approved in the US for SSc-ILD last year – is one of Boehringer’s top-selling drugs with sales growing 22% to €677 million ($751 million) in the first six months of 2019 from its established use in idiopathic pulmonary fibrosis (IPF).

There are estimated to be around 2.5 million people with systemic sclerosis worldwide, and there is no curative treatment with management focusing on symptom alleviation using phototherapy, physiotherapy and corticosteroid drugs. Lung disease is the leading cause of mortality, accounting for almost 35% of scleroderma-related deaths.

Analysts have suggested that the market potential for SSc-ILD could be almost as big as IPF, so approval in Europe could add additional sales momentum to Ofev.

At the moment there are hardly any drugs for scleroderma in clinical development, and the only near-term rival to Boehringer’s drug looks likely to be Swedish biotech Vicore Pharma’s VP01 in phase 2 trials for scleroderma as well as IPF.

CHMP round-up

The CHMP also recommended the approval of a new antibiotic at its meeting late last week, namely Shionogi’s antibiotic Fetcroja (cefiderocol) for the treatment of infections due to aerobic gram-negative organisms in adults with limited treatment options.

The antibiotic was approved last year by the FDA under the Fetroja brand name as a last-line therapy for complicated urinary tract infections (cUTI).

The CHMP also backed a generic form of Pfizer’s antibiotic Tygacil (tigecycline) for complicated skin and soft tissue infections (cSSTI) and complicated intra-abdominal infections (cIAI), Tigecycline Accord, from Accord Healthcare.

Positive opinions were also issued on new indications for two medicines, namely Takeda’s Alunbrig  (brigatinib) for use in ALK-positive non-small cell lung cancer and Celgene’s psoriasis therapy Otezla (apremilast) for oral ulcers associated with Behçet’s disease.

Meanwhile, a new subcutaneous formulation of Takeda’s Entyvio (vedolizumab) – currently given as an intravenous infusion – was recommended for approval by the EMA as a maintenance therapy in moderate to severe ulcerative colitis or Crohn’s disease.

The CHMP also said it had started looking into its accelerated approval of PharmaMar’s Yondelis (trabectedin) for relapsed ovarian cancer, after a clinical trial was stopped prematurely because an interim analysis found the drug didn’t extend survival in these patients when added to standard therapy.

The review will gauge whether Yondelis should stay on the market for ovarian cancer. It is also approved by the EMA as a treatment for soft tissue sarcoma.

The committee will also review medicines which had studies conducted at a research site in India operated by Panexcell Clinical Laboratories which recently failed a Good Clinical practice (GCP) inspection, to see whether the drugs should remain on the market.