The Business Cocktail

PMV Pharma Raises $74M, Aiming to Hit Cancer’s Hard Target- P53

PMV Pharmaceuticals is the latest startup to load up with cash in an attempt to home in on one of the toughest targets in cancer biology: the tumor suppressor protein known as p53. The company raised a $74 million Series B round from Topspin Biotech Fund, Euclidian Capital, InterWest Partners, OrbiMed Advisors, and Osage University Partners. PMV raised a $30 million Series A in 2014. The new cash will help PMV push into human clinical studies, though in its statement the startup didn’t say when those studies might begin. Like many of its peers, PMV wants to restore the function of mutated p53 with a drug, though it didn’t disclose exactly what its approach will be.

Argos Shares Plummet following Reports of Failed Results for Kidney Cancer Therapy

An Argos Therapeutics therapy that uses the immune system to fight kidney cancer has hit a wall after an analysis of the latest clinical trial data found that the experimental treatment was unlikely to work. Following the planned interim analysis of Argos’s Phase 3 clinical trial, the independent data monitoring committee recommended stopping the study for futility, the company announced this morning. Shares in Durham, NC-based Argos plummeted more than 62 percent to $1.65 on the news. Argos said that it is analyzing the preliminary data from the clinical trial and it plans to discuss that information with the FDA. In the meantime, Argos said that it plans to leave the clinical trial open.

Cidara Antifungal Flunks in Phase 2 Clinical Trial, Shares Sink

Cidara Therapeutics is halting work on an experimental topical antifungal drug designed to treat vaginal yeast infections after the compound wasn’t better than the current standard of care in a Phase 2 clinical trial. Investors frowned on the news, sending the company’s shares down more than 38 percent to $7.24 on 21st morning. Cidara is turning its attention to CD101 IV, which is in a Phase 2 trial for the fungal infection candidemia. Results for that clinical trial are expected in the fourth quarter. Cidara will also continue working on CD201, a potential treatment for infections caused by drug-resistant Gram-negative bacteria.

Cashing in On Duchenne Approval, Sarepta Sells Voucher to Gilead for $125M

Sarepta Therapeutics didn’t just get its first drug to market when the FDA approved the Duchenne muscular dystrophy drug eteplirsen (Exondys 51) last year—it got a potentially lucrative voucher from the FDA too. Sarepta sold the priority review voucher to Gilead Sciences in a deal worth $125 million. Sarepta will use the cash to help develop next-gen drugs for Duchenne. Priority review vouchers are awarded to companies that bring treatments to market for neglected tropical diseases and rare pediatric ailments, enabling a swifter review from the FDA, and potentially adding millions in revenue for a company, or giving a drugmaker a leg up over a competitor with a rival therapy.

Novartis and NHS Ayrshire & Arran launch new eye care facility in Scotland

Novartis Pharmaceuticals UK and NHS Ayrshire & Arran have announced the launch of a new facility designed specifically for people suffering from some of the most common forms of avoidable sight loss. The facility is set to support the delivery of a one-stop clinic for patients and is expected to transform the patients’ eye service by building an extension on to the existing Ophthalmology Outpatient Department.

The Business Cocktail

ALCMI, ALCF and Scancell partner to evaluate SCIB2 cancer vaccine for NSCLC

The Addario Lung Cancer Medical Institute (ALCMI) and the Bonnie J. Addario Lung Cancer Foundation (ALCF) have collaborated with UK-based Scancell to assess SCIB2 cancer vaccine to treat patients with non-small-cell lung cancer (NSCLC). SCIB2 is Scancell’s second ImmunoBody cancer vaccine platform currently under development. It stimulates the immune system to potentially treat and prevent cancer. Scancell has successfully completed a Phase I / II clinical trial with SCIB1 cancer vaccine by using it on patients suffering from melanoma. Along with having the ability to complement existing treatments, SCIB2 can also work in cases where current treatments either do not work or are not available.

Sun looks to unload Ohm Labs New Jersey plants in manufacturing consolidation

The Indian company is reportedly looking to sell New Jersey plants as part of a manufacturing consolidation. The facilities have been on the market for a couple of months and are expected to fetch about $100 million. Sun Pharma got the solid-dose, prescription and OTC manufacturing facilities in its 2015 buyout of Ranbaxy Laboratories, and is slimming down its manufacturing operations since the buyout, last year selling plants in Philadelphia, Pennsylvania, and Aurora, Illinois, to CDMO Frontida BioPharm. Before that, it struck a deal to sell a formulation plant in Bryan, Ohio, to Nostrum Laboratories, a Kansas City, MO-based generics maker, and announced the closure of a plant in Tipperary, Ireland.

Takeda and Ovid join forces to co-develop Drug for Rare Pediatric Epilepsies

In January 2017, Takeda and Ovid Therapeutics announced an agreement to co-develop a drug for rare pediatric epilepsies. Takeda’s compound, TAK-935, is at the heart of this agreement, with its continued development and commercialization in the US, Europe, Canada, and Israel being conducted by Ovid. Takeda will be developing the drug in Japan and other Asian markets. This unusual agreement also allows the companies to share the development and commercialization costs 50/50, and in the event of a successful launch to share profits equally as well.

Guardant and MD Anderson collaborate for liquid biopsy deal

Guardant Health and the University of Texas MD Anderson Cancer Center have struck a multiyear deal to push comprehensive liquid biopsy into the standard of care in cancer treatment. The commercial, research and development agreement will see Guardant helping MD Anderson build multiple liquid biopsy centers on site, according to a statement. The company launched its Guardant360 test in 2014 and says it is the most validated and sensitive liquid biopsy on the market.

Glooko and Ascensia integrate their offerings to boost diabetes management

In its second partnership announced this month, Glooko is teaming with Ascensia Diabetes Care to connect the latter’s blood glucose monitoring systems to its diabetes data management platform. Under the partnership, the pair will integrate Ascensia’s Contour Next One and Contour Plus One systems into Glooko’s platform. The goal is to improve diabetes data management and analytics for patients and physicians. Earlier this month, Glooko and Novo Nordisk joined forces to develop “digital health solutions” for diabetes management.

 

The Business Cocktail

Payers block Kaléo’s expensive EpiPen challenger

Kaléo reintroduced its Auvi-Q last week at a list price of $4,500 for a two-pack in an effort to capture some market share from Mylan’s EpiPen, which is listed at about $600 for a two-pack. Auvi-Q is set to launch next month. Under Kaléo’s pricing strategy, Auvi-Q will cost most patients $0 out-of-pocket. If an insurer refuses to cover the med, the company will step in and pay for that access, execs said last week. Uninsured patients can purchase the drug at a cash price of $360 for a two-pack. Instead, the strategy shifts the costs to insurers and pharmacy benefit managers. At a list price multiples higher than its competition, Kaléo Pharma’s revived Auvi-Q has hit resistance from some of the nation’s top pharmacy benefit managers and insurers. Cigna has said no to the idea, while Humana is not talking to the company and Aetna is restricting its product for now.

FTC settlement clears Endo from pay-for-delay liability; Watson, Allergan charged

According to the FTC complaint, Lidoderm was an important product for Endo back in 2011. That year, the company made $825 million in sales off the lidocaine patch, or 30% of its annual sales haul, meaning generic competition would pose “significant financial risks” to the company. Endo paid Watson at least $250 million to delay that competition, according to the feds. Through an “administrative complaint,” authorities are also going after Impax Laboratories, which they say received $112 million back in 2010 to delay a generic competitor to Endo’s Opana ER. Endo International has pledged to swear off pay-for-delay agreements. But even as the government moves to wrap up its case against Endo, authorities continue to pursue claims against Watson and Allergan.

Amgen hikes prices by single digits, with Enbrel matching AbbVie’s Humira boost

Amgen raised the price of its top-selling med, Enbrel, an 8.4% hike that followed a larger one just six months ago. It also came on the heels of an identical price hike for one of Enbrel’s key competitors, AbbVie’s Humira. Amgen executives say payer discounts will eat up most if not all of its latest hikes. The move follows a 28% increase for the anti-TNF blockbuster in 2015 and another boost of 9.9% in July 2016. During Amgen’s third-quarter 2016 conference call, commercial operations head Anthony Hooper said the company expects “relatively little benefit” on Amgen price changes in 2017 due to competitive payer negotiations.

Baxter paying $18M to settle federal case over sterile plant failings

Ignoring issues in a sterile manufacturing plant can lead to big problems, like FDA warning letters, which Baxter International received for a plant in North Carolina after mold was found in HEPA filters. But in rare cases, it can lead to even more severe penalties, like the $18 million-plus Baxter will pay to resolve a federal criminal case, as well as a civil matter brought by a whistleblower over the mold concerns.  Baxter will pay another $2.158 million to resolve a civil whistleblower case brought by Baxter employee Christopher Wall who had reported to the mold problem to plant management. Wall’s case alleged his concerns were overlooked and the plant continued to manufacture and sell product from the facility. Wall gets $431,535.99 as his share of the settlement.

The Business Cocktail

Sun Pharma & ICGEB announce exclusive collaboration to develop novel dengue vaccine

International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma Ltd. announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. ICGEB has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate.

Boehringer Ingelheim and Lupin Sign agreement for Diabetes Drug

Drug firms Boehringer Ingelheim and Lupin have entered into a partnership to co-market Empagliflozin used for treatment of type 2 diabetes in India. Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin’s specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through their existing sales force and network

Daiichi Sankyo Announces New Strategic Immuno-Oncology Research Collaboration with AgonOx

Daiichi Sankyo announced that it has entered into a strategic collaboration with AgonOx, Inc., a privately held biotechnology company developing a pipeline of novel immunotherapy drugs targeting key regulators of the immune response to cancer, to develop an undisclosed immuno-oncology target. Daiichi Sankyo and AgonOx will collaborate on preclinical development of the program. Following preclinical assessment, Daiichi Sankyo has an exclusive option to research, develop, manufacture and commercialize the program worldwide

Catalent Pharma Solutions partners with Samsung Bioepis Co. for Commercial Biosimilar supply

Catalent Pharma Solutions announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel® (etanercept), on behalf of the Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium. SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali.

Celltrion Healthcare and Teva enters into exclusive business collaboration agreement for Truxima™ and Herzuma™ in the U.S. and Canada

Celltrion’s commercial partner for its second and third biosimilars for the North America market has been determined. Celltrion announced that it has selected Teva Pharmaceuticals, as its exclusive commercial partner for Truxima and Herzuma in the US and Canada. Celltrion has applied for marketing authorization from the EMA last October. Mabthera (also known as Rituxan), the reference product to Truxima, was developed by Biogen and marketed by Roche.  Herzuma is a biosimilar to Herceptin, a breast cancer treatment antibody biologic drug developed by Genentech and marketed by Roche.

Anticoagulants (VTE & AF) Therapeutics Market is estimated to reach $17.2 billion by 2020

The Anticoagulants (VTE & AF) Therapeutics Market was around $11.4 billion in 2015 and is estimated to reach $17.2 billion by 2020 growing at a CAGR of 8.59% from 2015 to 2020.

DelveInsight Report “Anticoagulants-Market Insights & Drugs Sales Forecast (VTE & AF) -2020” provides an overview of the Anticoagulants andAtrial Fibrillation and Venous Thromboembolism. The Report majorlyemphasizes on the global Anticoagulants market size and market size of theAnticoagulants by 7 Major Markets (United States, EU5 (France, Germany,Italy, Spain, UK) and Japan). The Report also covers the market size of Atrial

Fibrillation and Venous thromboembolism along with the market sales of the Key drugs by VTE and AF indications. It provides comprehensive review of Market Drivers, Market Barriers, Anticoagulants with coverage of detailed profile, Cost of therapy, Safety and Efficacy profiles and SWOT analysis.

The global anticoagulants market is categorized based on different classes like vitamin K reductase Inhibitor, heparin, low molecular weight heparin, Factor Xa Inhibitor and thrombin inhibitors.

Global AF market was $7.2 billion in 2015 and is expected to grow to $12.5 billion by 2020 with an compound annual growth rate (CAGR) of 11.62% where as Global VTE market was $4.2 billion in 2015 and is expected to grow to $4.75 billion by 2020 with a compound annual growth rate (CAGR) of 2.44%

With the recommendation of usage of novel oral anticoagulants (NOAC) by International guidelines in line with their established safety, efficacy and compliance, we expect decrease of warfarin use at a CAGR of negative 3.20% from 2015-2020 due to patient preferences in switching from warfarin to NOAC at a significant rate.  Novel Oral Anticoagulants (NOAC) will continue to be first-line oral agents, accounting for 70% of major-market sales in 2015.

Insights from recent studies clearly indicates that Physicians are relatively satisfied with the NOACs due to its efficacy and positive safety profiles without the need for anticoagulation monitoring and
dose frequencies. Conventional therapies (i.e., Warfarin) will remain entrenched as first-line therapies for most of the AF and VTE patients, followed by novel oral anticoagulants (NOAC) in the developing and underdeveloped countries due to the high cost of NOAC medications.

For more information on this report email us at info@delveInsight.com.

DelveInsight is a leading Business Consulting and Market Research Firm. DelveInsight helps the clients to find answers relevant to their business, facilitating decision-making; identify potential market opportunities, competitor assessments and business environmental assessment. In addition to this DelveInsight also deals in providing custom research services in coherence with interest area of the clients.

Global atrial fibrillation market is expected to grow to $12.5 billion by 2020 with and compound annual growth rate (CAGR) of 11.62%

Global AF market was $7.2 billion in 2015 and expected to grow to $12.5 billion by 2020 with and compound annual growth rate (CAGR) of 11.62%. There are four NOACs which are indicated for the treatment of AF such as Xarelto, Eliquis, Pradaxa and Savaysa.

DelveInsight Atrial Fibrillation-Market Insights & Drugs Sales Forecast (AF) -2020 provides an overview of Atrial Fibrillation indication. The Report majorly emphasize on the global Anticoagulants market size and market size of the Anticoagulants by 7Major Markets (United States, EU5 (France, Germany, Italy, Spain, UK) and Japan). The Report also covers the market size of Atrial Fibrillation along with the market sales of the Key drugs by AF.  The Report provides comprehensive review of Market Drivers, Market barriers, Anticoagulants with coverage of detailed profile, Cost of therapy, Safety and Efficacy profiles and SWOT analysis.

With the new guideline by regulatory agencies has promoted the use of NOACs over warfarin. Atrial Fibrillation guidelines has also encouraged to use CHA2DS2-VASc score instead of the CHADS2 score for assessing stroke risk, which will cause a larger proportion of lower risk patients to receive anticoagulant treatment.

For more information email us @ info@delveinsight.com.

Global VTE market is expected to grow to $4.75 billion by 2020 with a compound annual growth rate (CAGR) of 2.44%

Venous Thromboembolism- Market Insights & Drugs Sales Forecast (VTE) -2020: New Report by DelveInsight suggests that the Global VTE market was $4.2 billion in 2015 and expected to grow to $4.75 billion by 2020 with a compound annual growth rate (CAGR) of 2.44%.

DelveInsight Report “Venous Thromboembolism-Market Insights & Drugs Sales Forecast Thromboembolism indication. The Report majorly emphasize on the global market size venous thromboembolism. The Report provides Anticoagulants market size and Anticoagulants by 7 Major Markets (United States, EU5 (France, Germany, Italy, Spain, UK) and Japan) in Venous Thromboembolism indication.   The Report provides comprehensive review of Market Drivers, Market barriers, Anticoagulants with coverage of detailed profile, Cost of therapy, Safety and Efficacy profiles and SWOT analysis,

Coagulation is an important phenomenon of body to stop external bleeding but when clots are formed in blood vessels, it can be lethal. Blood clots in arteries can lead to heart attack and when formed in the blood vessels of brain can lead to stroke. Thus, anticoagulants are used to prevent the formation of blood clots in the body. Anticoagulants are proved to be a beneficial medication for the treatment of Atrial fibrillation, Deep Vein Thrombosis, Pulmonary Embolism and Stroke.  Globally the overall incidence for Venous Thromboembolism (VTE) is increasing at a higher rate. For VTE, there are approximately 1 million cases in the United States each year, many of which represent recurrent disease. The increasing epidemiology of venous thromboembolism is a key driver for the global anticoagulants market.   The global anticoagulants market is categorized based on different classes like vitamin K reductase Inhibitor, heparin, low molecular weight heparin, Factor Xa Inhibitor and thrombin inhibitors.

The VTE market is distributed among different class of anticoagulants including LMWH, NOACs and Warfarins. Once the patient diagnosed with the DVT or PE, two choices are provided ie warfarin with a parenteral anticoagulant for at least the first 5 days and until the international normalized ratio (INR) is therapeutic or novel oral anticoagulants (NOAC). Xarelto (rivaroxaban) and Eliquis (apixaban) are the preferred therapies due to less major bleeding.

For more information email us at info@delveinsight.com

Pancreatic Cancer – Market Insights, Epidemiology and Market Forecast-2020

DelveInsight is a leading Business Consultant and Market Research Firm which has become the knowledge partner for biotechnology and pharmaceutical companies by providing competitive intelligence information which aids them to strategize and discover the target areas & potential customers for their products.

DelveInsight expertise has expanded from an initial focus on Pipeline & Marketed Reports to Market Forecasting and Epidemiology Reports.

Pancreatic Cancer -Market Insights, Epidemiology and Market Forecast-2020, report provides an insight on the forecast of a indication over a period of time which helps an organization to better understand the business development strategies from present and futuristic point of view.

Pancreatic Cancer-Market Insights, Epidemiology and Market Forecast-2020, provides clients with the detailed insights into epidemiology and market forecast of the indication in these countries. This report majorly includes:

  • Report covers the disease overview including etiology, path physiology, symptoms, diagnosis, disease management and current treatment options.
  • Marketed information including available prescription drugs, its patent and exclusivity details followed by drug sales till 2018.
  • The Report also covers the detailed global historical and forecasted epidemiological data covering United States, EU5 and Japan from 2010-2020.
  • It also provides Market size of Pancreatic Cancer for United States, EU5 and Japan from 2010 and forecasted Market size to 2020. This epidemiological analysis report will aid in the development of business strategies by providing a deep understanding of the trend shaping and driving the global insight market. Along with that, it quantifies the patient populations in the global indication market to improve product design, pricing, and launch plans.

DelveInsight is offering the Report at a price of USD 4,950 as a single user license, USD 9,900 as a site license and USD 14,850 as a Global/Enterprise License.

For more information on Indication – Market insights, Epidemiology and Market Forecast 2010-2020, email at info@delveInsight.com

Note: These types of reports require 7-10 working days.

About Us:

DelveInsight is a leading Business Consulting and Market Research Firm.  DelveInsight helps the clients to find answers relevant to their business, facilitating decision-making; identify potential market opportunities, competitor assessments and business environmental assessment. In addition to this DelveInsight also deals in providing custom research services in coherence with interest area of the clients.

Non-Hodgkin’s Lymphoma (NHL) – Market Insights, Epidemiology and Market Forecast-2020

DelveInsight is a leading Business Consultant and Market Research Firm which has become the knowledge partner for biotechnology and pharmaceutical companies by providing competitive intelligence information which aids them to strategize and discover the target areas & potential customers for their products.

DelveInsight expertise has expanded from an initial focus on Pipeline & Marketed Reports to Market Forecasting and Epidemiology Reports.

Non-Hodgkin’s Lymphoma (NHL) -Market Insights, Epidemiology and Market Forecast-2020, report provides an insight on the forecast of a indication over a period of time which helps an organization to better understand the business development strategies from present and futuristic point of view.

Non-Hodgkin’s Lymphoma (NHL)-Market Insights, Epidemiology and Market Forecast-2020, provides clients with the detailed insights into epidemiology and market forecast of the indication in these countries. This report majorly includes:

  • Report covers the disease overview including etiology, path physiology, symptoms, diagnosis, disease management and current treatment options.
  • Marketed information including available prescription drugs, its patent and exclusivity details followed by drug sales till 2018.
  • The Report also covers the detailed global historical and forecasted epidemiological data covering United States, EU5 and Japan from 2010-2020.
  • It also provides Market size of Non-Hodgkin’s Lymphoma (NHL) for United States, EU5 and Japan from 2010 and forecasted Market size to 2020. This epidemiological analysis report will aid in the development of business strategies by providing a deep understanding of the trend shaping and driving the global insight market. Along with that, it quantifies the patient populations in the global indication market to improve product design, pricing, and launch plans.

DelveInsight is offering the Report at a price of USD 4,950 as a single user license, USD 9,900 as a site license and USD 14,850 as a Global/Enterprise License.

For more information on Indication – Market insights, Epidemiology and Market Forecast 2010-2020, email at info@delveInsight.com

Note: These types of reports require 7-10 working days.

About Us:

DelveInsight is a leading Business Consulting and Market Research Firm.  DelveInsight helps the clients to find answers relevant to their business, facilitating decision-making; identify potential market opportunities, competitor assessments and business environmental assessment. In addition to this DelveInsight also deals in providing custom research services in coherence with interest area of the clients.

Nonalcoholic Steatohepatitis (NASH) – Market Insights, Epidemiology and Market Forecast-2020

DelveInsight is a leading Business Consultant and Market Research Firm which has become the knowledge partner for biotechnology and pharmaceutical companies by providing competitive intelligence information which aids them to strategize and discover the target areas & potential customers for their products.

DelveInsight expertise has expanded from an initial focus on Pipeline & Marketed Reports to Market Forecasting and Epidemiology Reports.

Nonalcoholic Steatohepatitis (NASH) -Market Insights, Epidemiology and Market Forecast-2020, report provides an insight on the forecast of a indication over a period of time which helps an organization to better understand the business development strategies from present and futuristic point of view.

Nonalcoholic Steatohepatitis (NASH)-Market Insights, Epidemiology and Market Forecast-2020, provides clients with the detailed insights into epidemiology and market forecast of the indication in these countries. This report majorly includes:

  • Report covers the disease overview including etiology, path physiology, symptoms, diagnosis, disease management and current treatment options.
  • Marketed information including available prescription drugs, its patent and exclusivity details followed by drug sales till 2018.
  • The Report also covers the detailed global historical and forecasted epidemiological data covering United States, EU5 and Japan from 2010-2020.
  • It also provides Market size of Nonalcoholic Steatohepatitis (NASH) for United States, EU5 and Japan from 2010 and forecasted Market size to 2020. This epidemiological analysis report will aid in the development of business strategies by providing a deep understanding of the trend shaping and driving the global insight market. Along with that, it quantifies the patient populations in the global indication market to improve product design, pricing, and launch plans.

DelveInsight is offering the Report at a price of USD 4,950 as a single user license, USD 9,900 as a site license and USD 14,850 as a Global/Enterprise License.

For more information on Indication – Market insights, Epidemiology and Market Forecast 2010-2020, email at info@delveInsight.com

Note: These types of reports require 7-10 working days.

About Us:

DelveInsight is a leading Business Consulting and Market Research Firm.  DelveInsight helps the clients to find answers relevant to their business, facilitating decision-making; identify potential market opportunities, competitor assessments and business environmental assessment. In addition to this DelveInsight also deals in providing custom research services in coherence with interest area of the clients.