Search This Blog

Monday, February 3, 2020

Inovio’s INO-3106 shows encouraging action in pilot study

Inovio Pharmaceuticals (INO -11.6%) announces encouraging data from a just-published pilot study evaluating immunotherapy INO-3106 in patients with recurrent respiratory papillomatosis, a rare disorder characterized by the development wart-like growths (papillomas) in the respiratory tract.
The results showed that INO-3106 generated an immune response and engagement and expansion of an HPV 6-specific cellular response, including cytotoxic T cells. Two participants who previously required ~two surgeries each year to manage their disease were able to delay the need for surgery to a “robust degree.” One was surgery-free for 584 days while the other has remained surgery-free for over 915 days.
Shares are down 12% on continued profit-taking from its coronavirus outbreak-stoked runup.
https://seekingalpha.com/news/3537363-inovios-inominus-3106-shows-encouraging-action-in-pilot-study

As China battles coronavirus, should other nations worry about drug supply?

Worries about pharma’s reliance on China for its supply of key drug ingredients have popped up in the U.S. from time to time before. Now, the rising coronavirus has sparked the fear again.
As of Sunday, China had reported more than 17,205 confirmed cases of 2019-nCoV in humans. The death toll has reached 361. The mushrooming case count and various measures aimed at thwarting the disease are straining medical supplies in China, though it’s mostly protection products, such as masks, running short so far.
But as the virus continues to spread across China and beyond, one question emerges: If China prioritizes drugs for its own use amid surging domestic demand—or if the outbreak spurs further bans on international travel and trade, such as the restrictions now imposed by the U.S.—can other parts of the world sustain an adequate drug supply?
There’s no question that China is a major supplier of drug ingredients to the U.S., especially for widely used generics. For example, according to U.S. International Trade Commission data cited in a U.S.-China Economic and Security Review Commission report (PDF), China accounted for a 70.4% share of U.S. antibiotic imports in 2013. Today, that number may be even higher at a dominant 97%, according to Gary Cohn, previously chief economic adviser to President Donald Trump, as quoted by Yanzhong Huang, a senior fellow for global health at nonprofit think tank the Council on Foreign Relations (CFR).
And questions about that dependence on Chinese sources for essential medicines have repeatedly surfaced in the U.S.—once as tainted valsartan was first traced to an API from China’s Zhejiang Huahai Pharmaceutical, once amid U.S.-China trade tension and once as an African swine fever threatened heparin supply. And that’s just in the last few years.
For instance, in the heat of the now partly resolved U.S.-China trade war, Li Daokui, an economist at Tsinghua University and an adviser to Beijing, raised the possibility of China curbing exports of antibiotics as a countermeasure.
“Just as some international analysts have pointed out, we are indeed at the mercy of others when it comes to computer chips, but we are the world’s largest exporter of vitamin and antibiotic ingredients,” Li said last March during a speech at a national advisory conference, as quoted by state-run Xinhua (Chinese). “If we cut back exports, some western countries’ medical system won’t operate well.”

China at least isn’t likely to throw the first punch. As CFR’s Huang noted in his blog post, China needs innovative finished drugs made in western countries for diseases such as cancer. However, the coronavirus epidemic adds a different fold of uncertainty: domestic demand.
Supplies of a traditional Chinese herbal concoction called shunaghuanglian immediately ran out both online and in pharmacies after state media reported Friday that the drug could “inhibit” the new deadly coronavirus.
The report cited research at the Chinese Academy of Science’s Shanghai Institute of Materia Medica and the Wuhan Institute of Virology. Even though the idea was quickly rejected by the wider science community, it does show China—with a population of 1.4 billion—can deplete drug supplies amid an epidemic. By that time, it simply might not have enough left for the rest of the world.
“I would be asking my supply chain folks, what do we have coming from China, what’s our inventory, and if we don’t have enough, can we get as much as fast possible?” Steven Lynn, an FDA official turned consultant, said in a Stat report. “And remember, this isn’t just a U.S. problem. It’s a global problem if China starts shutting down its borders.”

Multinational pharma companies say they are well prepared, though.
“Pfizer consistently and diligently monitors the supply of our medicines,” a Pfizer spokesman told FiercePharma in a statement Friday. He pointed to the company’s 40 self-owned sites and more than 200 suppliers globally, “which provide capacity and redundancy as needed.” Most of its finished products and APIs come from countries other than China, he said.
Johnson & Johnson is also on the lookout for the coronavirus situation. “We have robust business continuity plans in place to prepare for unforeseen events and to meet the needs of the patients, customers and consumers who depend on our products,” a J&J spokesperson said.
That includes “critical inventory” at major distribution centers outside high-risk areas, the spokesperson said, as well as working with external suppliers.
A Roche representative told FiercePharma the Swiss drugmaker has one API for global demand coming from China “with existing stock reserves and the opportunity to source from another location,” adding that the company has “robust plans for dealing with the impact of potential health crises.”
https://www.fiercepharma.com/pharma-asia/as-china-battles-coronavirus-should-other-countries-worry-about-their-drug-supply

BOQI International to Acquire China Medical Distributor

BOQI International Medical Inc. (BIMI) (“BIMI” or the “Company”) today announced that it has entered into a stock purchase agreement (the “Agreement”) to acquire Chongqing Guanzan Technology Co., Ltd., (“Chongqing Guanzan”) through its wholly-owned subsidiary Beijing Xin Rong Xin Industrial Development Co., Ltd. (“Buyer”)
Chongqing Guanzan is a Chinese medical distributor with distribution channels covering over 4,000 pharmacies, over 4,000 clinics, 50 hospitals and 130 pharmaceutical companies nationwide. Chongqing Guanzan also has about ten world-leading medical device suppliers such as Stryker, GE, Siemens, Philips and Olympus.
Pursuant to the Agreement, the Buyer will purchase all the issued and outstanding shares (the “Shares”) of Chongqing Guanzan. The aggregate purchase price for the Shares is RMB 100,000,000 (currently approximately $14,285,714), to be paid in 950,000 shares of common stock of the Company (the “Stock Consideration”) and RMB 800,000,000 in cash (the “Cash Consideration”). The Stock Consideration will be paid at closing and the Cash Consideration, which is subject to post-closing adjustments based on the performance of Chongqing Guanzan in 2020 and 2021, will be paid pursuant to a post-closing payment schedule. The closing of the agreement is expected to be on or about April 20, 2020, subject to necessary regulatory approvals.
“By joining BOQI International Medical, Chongqing Guanzan and our employees will benefit from its supply chain management, as well as the greater resources of a larger, public company,” said Xiaoping Wang, Chief Executive Officer of Chongqing Guanzan. “Importantly, we will maintain our continued commitment to outstanding product quality and strong relationships with suppliers and customers.”
“This is a milestone acquisition which substantially accelerates our pharmacy expansion and member growth in Southwest China,” said Mr. Tiewei Song, Chief Executive Officer and President of BOQI International Medical Inc. “Southwest China has about 200 million people and increasing market demand, which is a key area of our expansion strategy. The acquisition enhances our market position in Southwest China by bringing vital distribution channels, a best-in-industry management team, and local media influence. By consolidating new distribution channels, we can increase distribution channel efficiency and ensure supply during the current coronavirus outbreak. Based on our extensive engagement with Chongqing Guanzan over the past several months, we are confident that Chongqing Guanzan’s support will enable BOQI International Medical to execute on its strategy and next phase of growth.”
https://finance.yahoo.com/news/boqi-international-medical-enters-material-142335046.html

Abbott Has First-of-Its-Kind Trial to Assess New Therapy for Risk of Stroke

Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved a new trial designed to assess its Amplatzer™ Amulet™ Left Atrial Appendage Occluder for people with atrial fibrillation (AF) – a condition in which the normal rhythm of the heart’s upper chambers is disrupted and becomes erratic – who are at risk of stroke. The CATALYST trial is the first-ever clinical trial comparing the effectiveness of a left atrial appendage (LAA) closure device to a newer class of blood thinners, known as non-vitamin K antagonist oral anticoagulant (NOAC) drugs, which are currently the standard treatment option for AF.
Atrial Fibrillation is the most common sustained cardiac arrhythmia, with the prevalence in the U.S. projected to increase to 12.1 million by 2030.i  In some people with AF, the LAA – a small, naturally occurring pocket connected to the upper left chamber of the heart – can allow blood to pool, leading to increased risk of clot formation. If these clots become dislodged, they can travel to the brain, and cause a stroke, with AF-related ischemic strokes nearly twice as fatal compared to non-AF related strokes.ii, iii, iv  To reduce the risk of stroke, physicians may perform procedures to prevent blood clots from leaving the LAA in patients with AF who are unable to take blood thinners long-term.v, vi  Delivered to the heart through a small minimally invasive incision in the leg, the Amplatzer Amulet device allows physicians to permanently “seal off” the LAA.
The global, multicenter CATALYST trial will compare the effectiveness of the Abbott Amplatzer Amulet to NOACs as an alternative treatment option in an expanded population of AF patients. Blood thinners, first warfarin and now NOACs, are commonly the first-line therapy to reduce the risk of ischemic stroke – the most common type of all stroke – in patients with AF who are at an increased risk. However, risk of bleeding events, medication expenses, narrow therapeutic window, patient lifestyle, and medication compliance often limit blood thinner effectiveness in clinical practice.vii, viii, ix The CATALYST trial will randomize up to 2,650 subjects at 150 sites worldwide to assess whether sealing off the LAA with the Amulet device may be a viable alternative to a lifetime of these newer blood thinners.
“A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy,” said Vivek Reddy, M.D., director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York and the principal investigator for the CATALYST trial. “This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AF who are at an increased risk for ischemic stroke.”
The Amplatzer Amulet device received CE Mark approval in 2013 and is available in Europe and other countries that recognize CE Mark. At this time, the device is for investigational use only in the U.S.
https://www.biospace.com/article/releases/abbott-announces-first-of-its-kind-trial-to-assess-new-therapy-option-for-people-at-risk-of-stroke/

CTI Gets Accelerated Approval Pathway for Pacritinib in Thrombocytopenia

CTI BioPharma Corp. (Nasdaq: CTIC) today announced that following a meeting with the U.S. Food and Drug Administration (“FDA” or “the Agency”), CTI has reached agreement on an accelerated approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia (platelet counts <50,000/µL).  CTI will be amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of SVR rates on the first 168 patients, with an end-of-study analysis of TSS and OS following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, CTI intends to submit a New Drug Application (NDA) under the FDA’s subpart H regulations, subject to review of all available efficacy and safety data. Conversion to a regular approval of pacritinib would be anticipated following the successful end-of-study assessment of the secondary efficacy endpoints, and the completion of post-marketing requirements.

“Since the initiation of the PACIFICA trial in September 2019, we have been working diligently with the FDA to identify an expedited approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia,” said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. “Severely thrombocytopenic myelofibrosis patients (platelet counts <50,000/µL) have reduced survival and very limited therapeutic options. Pacritinib has now demonstrated clinical benefit in this population in three clinical trials, including two prior randomized Phase 3 studies, so we believe that pacritinib has the potential to change the treatment paradigm in this area of serious unmet medical need.”
Based on the new trial design, CTI expects to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022 if the SVR data is positive. Final study efficacy data is expected in 2023.
Concurrent with this press release, CTI is announcing a $60 million rights offering. For further details, see the concurrent press release relating to the rights offering.
https://www.biospace.com/article/releases/cti-biopharma-establishes-accelerated-approval-pathway-for-pacritinib-in-treating-myelofibrosis-patients-with-severe-thrombocytopenia/

Orgenesis Agrees to Sell Masthercell Global Contract Unit

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), today announced that Catalent Pharma Solutions has agreed to acquire Masthercell Global, Inc., a contract development manufacturing organization (CDMO) subsidiary of Orgenesis backed by Great Point Partners and SFPI-FPIM. Orgenesis anticipates that it will receive proceeds of approximately $127 million resulting from the transaction. The transaction is expected to close during the current fiscal first quarter of 2020. Orgenesis expects to use the net proceeds from the sale of Masthercell to continue to grow its point-of-care cell therapy business and to further the development of Advanced Therapy Medicinal Products. Additional details on the transaction will be available in the Company’s Current Report on Form 8-K filed today with the Securities and Exchange Commission at www.sec.gov and on the Company’s website at: https://ir.orgenesis.com/all-sec-filings.
Vered Caplan, Chief Executive Officer of Orgenesis, stated, “We are very proud of the developments and accomplishments at Masthercell Global, which has become a best-in-class contract development and manufacturing organization (CDMO) servicing many of the leading cell and gene therapy companies. We are also grateful to Great Point Partners and SFPI-FPIM for their tremendous support. Since we completed our acquisition of Masthercell Global in 2015, the business has grown rapidly along with this burgeoning industry. With Catalent’s expertise and resources, we believe Masthercell Global will be well positioned to continue on its current trajectory in order to meet the evolving needs of the industry. We believe the resources provided to Orgenesis by this transaction will enable us to significantly accelerate our point-of-care (“POCare”) cell therapy platform and we look forward to providing further updates.”

NCI grant boosts Artelo Bio

Thinly traded nano cap Artelo Biosciences (NASDAQ:ARTL) is up 60% premarket on robust volume in reaction to a $4.2M five-year NCI grant that will fund the advancement of its fatty acid binding protein 5 (FABP5) inhibitor program. Specifically, the grant will support research at Stony Brook University’s Institute of Chemical Biology and Drug Discovery, in collaboration with Cold Spring Harbor Laboratory and Artelo.
https://seekingalpha.com/news/3537263-nci-grant-boosts-artelo-bio-up-60-premarket