Leading Health and Life Sciences in Nova Scotia

NEWS RELEASE – BioNova Announces Motryx as the Winner of the Ninth Annual BioInnovation Challenge (BIC) at BioPort 2019

FOR IMMEDIATE RELEASE

November 6, 2019

BioNova Announces Motryx as the Winner of the Ninth Annual BioInnovation Challenge (BIC) at BioPort 2019

Halifax, NS – November 6, 2019 – Today Motryx from Nova Scotia was named the winner of BioNova’s ninth annual BioInnovation Challenge (BIC) business pitch competition at BioPort 2019. Motryx is developing high-resolution, wireless, water and temperature resistant data-loggers with data analysis capabilities.

“The BioInnovation Challenge has positioned us for fast acceleration,” Franziska Broell, of Motryx said, “We have benefitted not only from winning, but from the program and training it provided as a whole.”

Atlantic Canada’s best health and life science innovators participate in the BioInnovation Challenge (BIC) business pitch competition each year. The competition’s goal is to help ease the transition from research laboratory to market. Motryx will receive a prize package that includes $25,000 in seed funding and an advisory services package worth more than $30,000. Motryx was up against SeeChange Biochemistry and Fieldetect.

“Selecting a winner was difficult for our judges panel as all three finalists have what it takes to make their start up a success,” said Scott Moffitt, Executive Director of BioNova. “Congratulations to Motryx.”

The Judging Panel:
Jennifer Hamilton, PhD – Senior Director, New Ventures at Johnson & Johnson Innovation and Advisor to Johnson & Johnson’s Impact Investing team
Arif Aziz, PhD – Senior Manager, National Life Science SR&ED, MNP
Milos Todorovic, PhD – International Business Development Officer, Global Affairs Canada

-30-

Media Contact:
Shana Cristoferi, Marketing Manager, BioNova
902-830-9193
[email protected]

About BioNova
BioNova leads, accelerates, and advocates for Nova Scotia’s growing health and life sciences sector. Since 1993, BioNova has been accelerating the growth of its member companies. By hosting networking and educational events, and providing connections to potential funders and business resources, BioNova helps companies succeed.  While these companies commercialize life-changing research to improve healthcare, provide healthier food, and develop sustainable solutions, BioNova advocates on behalf of the sector. BioNova champions the sector’s cluster of world-class research facilities, incubator programs, and companies who, together, bring investment and jobs to Nova Scotia.  www.bionova.ca

Densitas Software Wins Procurement For DIMASOS Breast Screening Trial In Germany

See original news release here

Announcing our densitas densityai™ software will be deployed in up to 24 clinics throughout Germany as part of a procurement for a major breast cancer screening trial.

Our software will be used to provide breast density measurements at point of care to identify women for supplemental breast cancer screening as part of the DIMASOS 2 Trial.The announcement highlights not just the importance to this trial of the software’s unique ability to process prior ‘for presentation’ mammograms from a wide range of scanner vendors, but to any practical clinical deployment.

What is the objective of the trial?

The trial will aim to establish whether combined mammography and ultrasound exams can improve early breast cancer detection. It will also explore if this can be done feasibly and cost-effectively in standard screening workflow.

Who is leading the trial?

The trial will be led by Prof. Dr. Sylvia H. Heywang-Köbrunner, M.D., Head of Referenzzentrum Mammographie München, internationally recognized for her pioneering work in contrast-enhanced breast MRI and modern biopsy procedures.

She will be using densitas densityai™ breast density measures to establish a supplemental ultrasound screening protocol in the DIMASOS 2 trial.

When asked about the trial, Dr. Heywang-Köbrunner said:

“Women with dense breasts are subject to the masking effect of mammographic density and its association with breast cancer risk. The objective of the DIMASOS 2 trial is to test whether combined mammography/ultrasound exams can improve early cancer detection and if this can feasibly and cost effectively be done in routine screening workflow.

The unique ability of the Densitas® software to analyze prior ‘for presentation’ mammograms from a wide range of mammography scanner vendor models is pivotal to this trial and is important for any practical clinical deployment.” 

What is our densitas densityai™ software used for?

Our densitas densityai™ software delivers fully automated, standardized, and reproducible breast density assessments from standard DICOM clinical use mammograms.

Results from densitas densityai™ are generated by two distinct algorithms that decouple the breast density assessment into quantitative and qualitative scales in alignment with the ACR BI-RADS 4th and 5th edition density classification system.

These results can be incorporated into breast cancer risk models to provide standardized and reproducible patient-specific risk estimates.

Mo Abdolell, CEO of Densitas, had this to say about the procurement:

“Being selected as the vendor of choice to provide automated breast density assessment for the DIMASOS 2 Trial attests to our modern AI-driven technology superseding dated breast density algorithms developed prior to the introduction of the ACR BI-RADS 5th ed. density scale in 2013.

Densitas densityai™ processes the same clinical use images that radiologists examine, setting it apart by enabling seamless PACS-centric integrations and retrospective auditing capabilities of routinely archived exams. This makes it an ideal fit for the DIMASOS 2 trial.

More broadly this also simplifies clinical deployments, and is more cost effective and deeply integrated into radiologist reporting workflows with key applications and platforms that include Nuance PowerScribe One and PowerScribe 360 Reporting, The Nuance AI Marketplace, Blackford Platform and Curated Marketplace,  Ikonopedia structured breast reporting and tracking software, TeraRecon’s AI interoperability platform, EnvoyAI, and Three Palm Software’s WorkstationOne.”


Get in touch with our team

Interested in learning more about how our suite of solutions for digital mammography  is helping move the needle in breast cancer screening?

Schedule a demo with a member of our sales team to get a tailored walkthrough of our entire suite of solutions offered as part of the densitasai™ platform.

ENTREVESTOR: IMV Inc. entering a crucial phase in late 2019

Read original article here

IMV Inc., the Dartmouth company developing a delivery platform for immunotherapy drugs, is entering a critical phase of its 16-year history as it will soon learn the results of key Phase 2 clinical trials.

The company is conducting a range of Phase 2 trials for its flagship drug candidate DPX-Survivac, including tests in partnership with the multi-national pharma company Merck & Co. The results of these Phase 2 trials — which establish efficacy, or whether a drug does what its maker says it does – should be known by the end of this year.

If the results are positive, the company will have some key decisions to make in the next year. Should it bring Survivac to market with a partner or on its own? Could it sell Survivac and focus on the development of other drug candidates? Could the whole company be sold? Whatever the outcome, IMV is approaching the juncture that attracted investors when the company launched in 2003.

“Most of the clinical results will be in by the end of the year,” said CEO Frederic Ors in an interview last week. “So in the second half of this year or the first half of 2020, we have really got to think what is the best way forward for the company.”

Developed from a Dalhousie University experiment to deliver birth control to seals on Sable Island, DPX-Survivac uses the body’s immune system to battle diseases by delivering doses of medication over a prolonged period. Often working as a delivery platform for other drugs, Survivac locates Survivin, a substance found in the outer layer of cancer tumors, then attacks the tumors repeatedly.

The most important trials are those into the drugs’ impact on ovarian cancer, an especially lethal affliction, and Ors said the company hopes the drug will be effective in prolonging the lives of people suffering with hard-to-treat forms of cancer.

“It’s one thing to be able to stop cancer but what’s important is how long you are able to maintain that,” said Ors. “In ovarian cancer, we have one patient who has been treated with DPX-Survivac for three years now.”

In its most recent financial statements, IMV said Survivac has displayed “durable clinical benefit” and “positive new data” during clinical trials, which are taking place in six locations. But nothing is certain until it announces the trial results.

In terms of what decisions the company could reach once the results are known, Ors noted that IMV shares are listed not only in Toronto but also on the Nasdaq exchange in New York. That positions the company in theory to raise enough capital to bring the drug to market on its own.

A dark cloud hovering over the IMV story is the experience of American immunotherapy company Incyte Corp., which had partnered with Merck for trials of its drug Epacadostat. In April 2018, Incyte announced trials showed Epacadostat did not help melanoma patients, hammering the stock of all immunotherapy companies, including IMV.

IMV shares closed Thursday down 2.7 percent at $3.97, meaning they have 44 percent of their value in the past year.

Yet IMV has been able to raise capital. In March, it raised $29.5 million by selling shares to investors, and Ors said IMV now has enough capital to last through 2020.

Though its shares have been on a rollercoaster ride the past three years, IMV as an organization has continued to grow, and now employs 64 people. One highlight of this is that three-quarters of its staff are female, and women make up half of its management team. Ors said he feels good about the company as he awaits the clinical trial results.

“It’s a good thing to be here,” he said. “A lot of companies actually never get the chance to be in this stage of development. We feel very strong about our pipeline and that it has a high chance to succeed.”

Mallinckrodt Agrees to Sell BioVectra Inc. to H.I.G. Capital for $250 Million

Read original news release here

— Transaction continues to advance Mallinckrodt’s strategic focus on branded biopharmaceuticals by monetizing a non-core business —
— H.I.G. Capital to support BioVectra leadership and its attractive growth plan —

STAINES-UPON-THAMES, United Kingdom and MIAMI – Sept. 10, 2019 – Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it has entered into a definitive agreement to sell its wholly owned subsidiary BioVectra Inc. to an affiliate of H.I.G. Capital, a leading global private equity investment firm, for approximately $250 million, including fixed consideration of $175 million, comprised of an upfront payment of $135 million and a long-term note for $40 million, and contingent payments of up to $75 million, enabling Mallinckrodt to capture future BioVectra growth potential.

BioVectra is a contract development and manufacturing organization (CDMO) whose global client base includes many of the top biopharmaceutical companies in the world. The company has a unique mix of capabilities, with core growth engines in complex chemistry, biologics and drug development. BioVectra will continue to supply an active pharmaceutical ingredient supporting Mallinckrodt’s specialty brands business under a long-term arrangement. The transaction is anticipated to include all of BioVectra’s sites in Prince Edward Island and Nova Scotia, Canada, as well as its employee base.

“This transaction continues to advance Mallinckrodt’s strategic focus on branded, high-growth biopharmaceuticals by monetizing a non-core business,” said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt. “While we recognize the longer-term growth potential for BioVectra, we believe that the structure of this deal enables us to participate in the future success of the business, and therefore we see this sale as the best option for both Mallinckrodt and BioVectra moving forward.”

“We are excited to support BioVectra’s exceptional leadership and highly dedicated employees,” said Mike Gallagher, Managing Director at H.I.G. Capital. “BioVectra demonstrates a tremendous ability to generate robust organic growth and utilizes a broad set of technical capabilities to deliver outstanding service and quality. They are completing major capital expenditure programs to significantly expand capacity and the company is well positioned to capitalize on growing demand for their services.”

The transaction is expected to close in the fourth quarter of 2019, subject to customary closing conditions. It is not anticipated that the sale will have any material tax impact to Mallinckrodt. The company intends to use the proceeds from this divestiture consistent with its previously disclosed capital allocation priorities.

Goldman Sachs & Co. LLC served as financial advisor and Latham & Watkins LLP served as legal advisor to Mallinckrodt in connection with the transaction.

Wells Fargo Securities LLC served as financial advisor and McDermott Will & Emery LLP served as legal advisor to H.I.G. Capital.

About BioVectra

BioVectra is a CDMO that serves global pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients (APIs). An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in:

  • cGMP microbial fermentation
  • Complex chemistry – high potency APIs
  • Biologics
  • Formulation development

For more information about BioVectra, please visit www.biovectra.com.

About Mallinckrodt

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company’s Specialty Brands reportable segment’s areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.

About H.I.G. Capital
H.I.G. is a leading global private equity and alternative assets investment firm with more than $34 billion of equity capital under management.* Based in Miami, and with offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, and Atlanta in the U.S., as well as international affiliate offices in London, Hamburg, Madrid, Milan, Paris, Bogotá, Rio de Janeiro and São Paulo, H.I.G. specializes in providing both debt and equity capital to small and mid-sized companies, utilizing a flexible and operationally focused/value-added approach:

  1. I.G.’s equity funds invest in management buyouts, recapitalizations and corporate carve-outs of both profitable as well as underperforming manufacturing and service businesses.
  2. I.G.’s debt funds invest in senior, unitranche and junior debt financing to companies across the size spectrum, both on a primary (direct origination) basis, as well as in the secondary markets. H.I.G. is also a leading CLO manager, through its WhiteHorse family of vehicles, and manages a publicly traded BDC, WhiteHorse Finance.
  3. I.G.’s real estate funds invest in value-added properties, which can benefit from improved asset management practices.

Since its founding in 1993, H.I.G. has invested in and managed more than 300 companies worldwide. The firm’s current portfolio includes more than 100 companies with combined sales in excess of $30 billion. For more information, please refer to the H.I.G. website at www.higcapital.com.

*Based on total capital commitments managed by H.I.G. Capital and affiliates.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
Statements in this document about Mallinckrodt that are not strictly historical, including statements regarding the proposed divestiture; the expected timetable for completion of the divestiture; the potential use of proceeds from the divestiture; payment on the long-term note and future contingent payments; future financial condition and operating results; economic, business, competitive and/or regulatory factors affecting Mallinckrodt’s businesses; and any other statements regarding events or developments that the company believes or anticipates will or may occur in the future, may be “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve a number of risks and uncertainties.

There are a number of important factors that could cause actual events to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include risks and uncertainties related to, among other things: the parties’ ability to satisfy the conditions to the divestiture, and complete the divestiture on the anticipated timeline or at all; the buyer’s ability to make payments on the long-term note or future contingent payments; general economic conditions and conditions affecting the industries in which Mallinckrodt operates; the commercial success of Mallinckrodt’s products; Mallinckrodt’s ability to realize anticipated growth, synergies and cost savings from acquisitions; conditions that could necessitate an evaluation of Mallinckrodt’s goodwill and/or intangible assets for possible impairment; changes in laws and regulations; Mallinckrodt’s ability to successfully integrate acquisitions of operations, technology, products and businesses generally and to realize anticipated growth, synergies and cost savings; Mallinckrodt’s and Mallinckrodt’s licensers’ ability to successfully develop or commercialize new products; Mallinckrodt’s and Mallinckrodt’s licensers’ ability to protect intellectual property rights; Mallinckrodt’s ability to receive procurement and production quotas granted by the U.S. Drug Enforcement Administration; customer concentration; Mallinckrodt’s reliance on certain individual products that are material to its financial performance; cost containment efforts of customers, purchasing groups, third-party payers and governmental organizations; the reimbursement practices of a small number of public or private insurers; pricing pressure on certain of Mallinckrodt’s products due to legal changes or changes in insurers’ reimbursement practices resulting \from recent increased public scrutiny of healthcare and pharmaceutical costs; limited clinical trial data for Acthar Gel; complex reporting and payment obligations under healthcare rebate programs; Mallinckrodt’s ability to navigate price fluctuations; future changes to U.S. and foreign tax laws; Mallinckrodt’s ability to achieve expected benefits from restructuring activities; complex manufacturing processes; competition; product liability losses and other litigation liability; ongoing governmental investigations; material health, safety and environmental liabilities; retention of key personnel; conducting business internationally; the effectiveness of information technology infrastructure; and cybersecurity and data leakage risks; Mallinckrodt’s substantial indebtedness and its ability to generate sufficient cash to reduce its indebtedness; and any future actions taken with respect to the Specialty Generics business.

These and other factors are identified and described in more detail in the “Risk Factors” section of Mallinckrodt’s Annual Report on Form 10-K for the fiscal year ended December 28, 2018. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.

CONTACTS

Investor Relations
Mallinckrodt:
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
[email protected]

Media
Mallinckrodt:
Daniel Yunger
Kekst CNC
212-521-4879
[email protected]

BioVectra:
Jordan MacGregor
Communications and Marketing Manager
BioVectra Inc.
902-566-9116 ext. 6376
[email protected]

H.I.G. Capital:
Mike Gallagher
Managing Director
305-379-2322
[email protected]

Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2019 Mallinckrodt. 9/19

ACOA NEWS RELEASE: Panag Pharma providing effective, non-addictive plant-based pain management

Halifax biotech company developing safe, cutting-edge products to ease chronic pain, inflammation

July 11, 2019 – Halifax, NS – Atlantic Canada Opportunities Agency
Innovative new treatments for pain management improve the daily lives of Canadians. Panag Pharma Inc. is developing a line of plant-based remedies to fight chronic pain and inflammation, helping people enjoy a better quality of life, and growing Atlantic Canada’s life sciences sector.

The Halifax biotechnology company is creating a family of both over-the-counter and prescription cannabinoid-based products that provide safe, effective, non-addictive pain management. The treatments act directly on the pain receptors in the body and are used for wound healing, treating irritated skin and relieving cold sores, among other applications. Unique in the world, these natural medications enable the company to create highly skilled jobs and position it well for future growth.

Today, Andy Fillmore, Parliamentary Secretary to the Minister of Canadian Heritage and Multiculturalism and Member of Parliament for Halifax, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency (ACOA), announced support for Panag Pharma Inc. as it develops and commercializes its innovative products.

The Government of Canada is making smart investments that will create good, highly skilled jobs in our country. It is helping small and medium-sized businesses to start-up, expand or modernize and supporting not-for-profit industry organizations to fuel business growth. Support for this project is one way the Government of Canada is working to achieve its Atlantic Growth Strategy outcome of long-term economic prosperity in the region.

Quotes
“Innovation that focuses on the commercialization of research to improve the quality of people’s lives can have far-reaching global impacts. That is why the Government of Canada is committed to projects such as this one that showcase the best of what Atlantic Canada offers, providing quality bio-innovations that attract investment and talent and advance regional economic prosperity.”
– The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development, and Minister responsible for ACOA

“When a local organization develops groundbreaking solutions to treat problems like chronic pain, it not only improves the daily lives of Canadians, but also bolsters development of the life science sector in the region. The Government of Canada is proud to support local businesses like Panag Pharma that spur economic growth, create highly skilled jobs and make the world a better, and less painful, place.”
– Andy Fillmore, Parliamentary Secretary to the Minister of Canadian Heritage and Multiculturalism and Member of Parliament for Halifax

“We are extremely pleased to have the support of the ACOA. This contribution clearly underlines the confidence the Agency has in our strategic direction to further grow our business and to our commitment to the Province of Nova Scotia and Atlantic Canada. Our management and employees are grateful for the opportunities this financing presents.”
– Chris MacLean, Chief Operating Officer, Panag Pharma Inc

“Today’s announcement reminds me of the expression that it takes a village. With the ingenuity and innovation of our life sciences group Panag, the marketing expertise of Tetra Natural Health, the licensing skills of Tetra Bio-Pharma, assistance with facilities from Dalhousie University and the generosity and confidence of the Atlantic Canada Opportunities Agency, we are able to showcase what collaboration can accomplish and it is something we should all be justifiably proud of.”
– Dr. Bill Cheliak, Chairman of the Board of Directors of Tetra Bio-Pharma Inc.

Quick Facts
 Panag Pharma is a wholly owned subsidiary of Ontario’s Tetra Bio-Pharma. The Panag Pharma team of PhD scientists and medical doctors are leading researchers and clinicians in the area of pain treatment and management. They bring a combined experience of more than 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions.
 Panag Pharma Inc. plans to produce AWAYE™, a topical over-the-counter medication for the temporary relief of aches and pains of muscles and joints associated with one or more of strains/sprains involving muscles, tendons, and/or ligaments, arthritis, simple backache and/or lumbago. The product, which is manufactured in New Brunswick, is already Health Canada approved and has a Natural Product Number. It is currently undergoing clinical trials and will be available through online distribution, over the counter in pharmacies, and by prescription.  Other treatments for cold sores, hemorrhoids, interstitial cystitis and corneal ulcers are in development.
 The Government of Canada is providing a repayable contribution of $500,000 to Panag Pharma Inc. through ACOA’s Business Development Program.
 The BDP primarily assists Atlantic Canadian entrepreneurs who want to start a business, increase productivity or improve operations. Investments under the BDP address any gap that may arise if an application does not fit within ACOA’s Regional Economic Growth through Innovation (REGI) program.
 The Business Development Program continues to build on the objectives of Innovation and Skills Plan, a multi-year strategy to create well-paying jobs for the middle class and those working hard to join it.

Contacts
Chris Brooks
Director, Communications and Outreach
Atlantic Canada Opportunities Agency
902-426-9417 / 902-830-3839 (cell)
[email protected]

Chris MacLean
Chief Operating Officer
Panag Pharma Inc.
902-499-6959 (cell)
[email protected]

energi PR
Marissa Zanti
Vice-President, Healthcare
437-215-6888 (cell)
[email protected]