Innomar Strategies buys pharma and healthcare regulatory consultancy TPIreg

06 June 2018 Consulting.ca

Innomar Strategies, a Canadian specialty pharmaceuticals service provider, has acquired Hamilton-based boutique consultancy Therapeutic Products (TPIreg). TPIreg specializes in regulatory and quality assurance services for pharma and healthcare industry clients in North America.

From treating the common cold, to malaria and everything in between, people look to drugs to preserve and improve their health. And new drugs are a big business, with the pharmaceutical industry investing about US$12.6 billion into new drug development annually. But before a doctor or hospital can prescribe them, new drugs have to go through extensive testing and regulatory requirements, the intensity of which can depend on the jurisdiction to which the new drug is being marketed.

In the US, drugs take an average of 12 years and $350 million to make it from the lab to pharmacy shelves. After first undergoing years of lab testing and proving the new drug works on animals to the FDA, the drug will enter three phases of human clinical trials – proving the drug’s safety and efficacy. After successful clinical results, the drug will be submitted to the FDA for review: in the US, the review process takes an average of 322 days; 366 days in Europe; and 393 days in Canada.

Getting through the regulatory process surrounding pharmaceutical regulation can be a long, complex, and expensive affair. As such, some companies will turn to specialist consultancies for support in the regulatory process. One such firm is Therapeutics Products Inc. (TPIreg), a boutique consultancy founded in 2013 and based out of Hamilton, ON. TPIreg provides regulatory consulting services to the North American pharmaceutical, biotechnology, medical device, natural health products, and cosmetic industries – supporting business of all sizes in developing a regulatory strategy that helps moves products to market quicker and more successfully.Innomar Strategies acquires pharma and healthcare regulatory consultancy TPIreg On May 3, Innomar Strategies – a leading specialty pharmaceuticals service provider in Canada – announced that it has acquired TPIreg. With the acquisition, Oakville-based Innomar – a part of drug wholesaling giant AmerisourceBergen – becomes the first full service distributor and support services company in the Canadian specialty healthcare market offering a full suite of commercialization services. Innomar helps its clients bring products to market with its commercialization services – including market access, patient support programs, clinic services, and pharmacy and logistics management. With the addition of TPIreg, Innomar adds regulatory consulting to its comprehensive service suite.

“At Innomar Strategies, we are committed to advancing the commercialization of specialty pharmaceuticals and delivering value to our patients and partners across the Canadian healthcare system,” said Innomar Strategies President Guy Payette. “TPIreg is dedicated to this same mission and we believe that together, our best-in-class combination of resources, solutions and expertise allows us to offer customers a true integration of commercialization services, including supporting full market authorization into Canada.”

TPIreg founder Anne Tomalin – a leading expert in Canadian pharmaceuticals regulation – will join Innomar, along with her team of skilled consultants. They will support Innomar in the areas of regulatory marketing and clinical trial applications, quality assurance, drug establishment licensing (DEL), and post-marketing regulatory activities. Tomalin brings over 25 years of industry experience to Innomar, as well as strong relationships with Canadian regulators.

“TPIreg will benefit from Innomar’s broad expertise and looks forward to contributing to a suite of commercialization services for companies wanting to enter the pharmaceutical market in Canada,” said Tomalin. “We are excited to join Innomar and accelerate our pace of innovation.”

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Canadian cannabis firms have attractive international opportunities, MNP reports

18 April 2019 Consulting.ca

Accounting and consulting firm MNP has released a report examining the comparative favourability of international cannabis markets.

As the first G7 country to legalize recreational cannabis, Canadian businesses are in an advantageous position to steer the emerging sector. However, Canada’s market is still a small one in the global scale of things. As in the case of other industries like manufacturing or natural resources, Canada’s cannabis firms need to pursue opportunities abroad in order to compete globally and unlock true growth potential.

"Canadian cannabis firms have the financial capital, intellectual capital, human capital, and a supportive policy framework to germinate the seeds of international success," Glenn Fraser, MNP's national cannabis co-leader, said. "Whether opportunities blossom depends on how effectively they leverage those advantages to get in on the ground floor of new markets. The time is now for Canadian cannabis companies to take a leadership role and replicate the Canadian model in new environments."

For now, only Canada and Uruguay have legalized recreational cannabis sales on a national level. However, numerous countries have legalized medical marijuana, and more still are contemplating recreational legalization, encouraged by Canada’s example as well as the changing attitudes of citizens.

MNP, a nationwide accounting and consulting firm with a strong cannabis advisory practice, recently released an illuminating report on the comparative attractiveness of international cannabis markets. The firm analyzed 16 international markets with dynamic cannabis sectors, considering factors like available financing, taxes and fee structures, and policy maturity. Though no markets received top marks across all categories, several still showed great promise.

Financing opportunities

Accessing capital, banking, and financial services can be a challenge in some markets, but remains an important part of market viability and business success. As such, MNP’s report analyzed the relative ease of accessing capital through public or private markets, as well as the availability of banking services.

Israel, Switzerland, Australia, and Malta emerged as the markets with the best financing opportunities. Israel’s cannabis sector, which has seen strong investment from Canadian firms, has also been buoyed by the anticipated legalization of exports. The Israeli market is largely supported by private equity firm iCan, which represent firms from more than 40 countries.

Switzerland’s cannabis market has also seen heavy investment from Canada, while the SIX Swiss Exchange and Bern exchange provide ample access to further capital. Venture capital is also expanding rapidly.

Australia, meanwhile, has the Australian Stock Exchange, which is already home to more than 20 cannabis stocks, including AusCan, Bod Australia, and Atlas Pearls.

Malta has strong access to capital though the Malta Stock exchange, as well as investment from banks. The small island nation has a particularly vibrant emerging medical cannabis sector, which has largely been built from international investment. "If Canadian businesses want to build eminence in new countries, they need to involve themselves in cannabis' continued integration into healthcare," David Danziger, senior vice president, assurance, MNP, said. 

"Companies who are already active in regions with a burgeoning medical market will have a clear advantage – both in terms of brand awareness, infrastructure, and international relationships – if and when those areas transition to recreational legalization," Danziger added.

Colombia, Jamaica, Denmark, Germany, and the UK were tagged as mid-level markets for financing opportunity, while Uruguay, Mexico, Netherlands, Portugal, Italy, Africa, and Asia were on the low-end.

Taxation and fees

Another central factor is the level of taxation and fees, which determine overall profitability, but also cannabis sector viability – set taxes and fees too high, and consumers will flock to the black market instead of buying overpriced legal pot. Uruguay (corporate tax rate 25%), Portugal (21%), and Jamaica (25%) were deemed as having the most favourable tax and fee burdens. Asia also entered the top tier, with China holding a corporate tax rate of 25%, and Thailand carrying a favourable 20% rate.

The UK, Netherlands, Australia, and Mexico were in the middle range, while Colombia, Israel, Switzerland, Malta, Italy, Denmark, Germany, and Africa were in the high-taxation range. All of the countries in the mid and high tier for taxation were hampered by either higher corporate tax rates, value added taxes (usually in 20% range), or a combination of both.

Policy maturity

Colombia, Jamaica, Australia, Malta, and Germany have the most mature and open cannabis policy environments, according to the MNP report. Jamaica is setting itself up as a premier legal cannabis producer, with progressive cannabis laws and dispensaries that allow tourists to purchase medical cannabis.

Colombia is creating a strong export market, with 80 companies producing cannabis products, many with international investment. The sale of dried cannabis for medicinal purposes, is, however, still barred.

Australia has a strong amount of domestic production underway with investment from Canadian firms, and recently permitted cannabis exports. There is also the belief that the government will start reimbursing medical marijuana in the years to come.

Though it has a miniscule population, Malta’s cannabis industry has attracted heavy international investment. The country’s high cost-per-gram paid by patients, as well as its liberal medical cannabis importation policies, make the country an attractive target.

Finally, Germany has perhaps the most advanced medical cannabis market, with its own government agency and costs coverage by the national health plan. The number of insured patients and medical cannabis imports are both on the rise, and some executives believe recreational legalization is on the horizon.

Uruguay, Israel, Italy, the UK, and Mexico were deemed to have mid-level policy favourability, while the Netherlands, Switzerland, Portugal, Denmark, Africa, and Asia had low-end policies. The Netherlands, despite its image as a pot haven of sorts – especially in Amsterdam – is actually just lax on enforcement, as the drug is still federally illegal. Many of the countries on the list have decriminalized personal possession and consumption of marijuana, but its sale and production remains illegal (outside of medical parameters). 

Overall, Jamaica and Australia emerged as perhaps the most attractive cannabis markets, with Australia in the high tier for financing and policy, and mid tier for taxation. Jamaica, meanwhile, has high-tier policy, mid-level financing, and a low-tax environment.

Looking forward, MNP advises Canadian firms to double down on their competitive advantages, while building a strong brand at home as opportunities open up abroad. "It's important for local cannabis companies to consider their areas of expertise and invest heavily in owning that position in the market," Fraser said. "The most valuable international opportunities will go to those companies who have developed a sustainable (and transferable) competitive advantage in conjunction with a recognizable brand in their home market."