Teva's drug pipeline could contain blockbusters

Teva  photo: Reuters
Teva photo: Reuters

Life after Copaxone: Teva is expecting the results of five clinical trials this year likely to gain FDA approval.

Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA; TASE: TEVA) Copaxone war is over. It would be a mistake, however, to think that Copaxone is the only arrow in Teva's bow. Teva has been moving forward with a wide range of developments in recent year, including both generic and innovative drugs. The company's innovative portfolio is interesting, and includes a number of potential blockbusters.

An examination of Teva's innovative drug pipeline puts the flood of recent reports about Teva, some well-founded and other less so, in a different light. It is true that the expiration of the Copaxone patent is significant for the company, but it appears that Teva made important preparations for this event, which should be taken into account before writing off the company.

Background

For the most part, Teva is a generics company that attacks other companies' patents and makes its own generic versions of their drugs. In order to keep things in their proper proportion, keep in mind that Teva is the world's largest generics company and one of the world's leading pharmaceutical corporations, with 57,000 employees in 80 countries and sales of 16,000 different products in 100 countries.

As of the end of 2016, Teva had 87 manufacturing sites and 26 clinical R&D sites. The company produces 120 billion tablets a year, and its sales totaled $22 billion in 2016. The largest generics company in both the US and Europe, Teva is among the top three generics companies in 40 markets around the world.

Teva's innovative drug pipeline

Teva's innovative drug portfolio strategy focuses on attempt to provide a solution to patients whom it believes currently have no solution. Teva is concentrating on the central nervous system, including multiple sclerosis, movement disorders, degenerative diseases, migraines and pain, and respiratory disorders.

As of the end of 2016, Teva's innovative portfolio includes quite a few developments. Teva believes that it will obtain results of five clinical trials this year, leading to five request for US Food and Drug Administration (FDA) approval.

Furthermore, Teva expects approval for seven innovative drugs this year, after having received approval for three new innovative drugs last month (out of the seven waiting for approval). The already approved drugs are Fluticasone Salmeterol MDPI, Vantrella, and Fluticasone Propionate MDPI.

One important innovate drug currently in Phase III clinical trials is for treatment of migraine headaches. As of now, this drug has been developed into two types of drugs: one for chronic migraines and one for migraine episodes. Teva has continued this important development, and has also developed another drug for treatment of cluster headaches.

In principle, Teva does not provide monetary estimates for products in development, but forecasts by the analysts for development of its drugs for migraines and severe headaches mention a market of $3 billion a year in which there is currently no dominant drug.

In September 2016, Morgan Stanley investment bank analyzed the migraine treatment market, and estimated that Teva would achieve peak sales of $1.7 billion a year (in a possible range from $600 million to $3 billion).

A Citigroup report from March 2016 estimated that the products for treatment of migraines, movement disorders, and Huntington's Disease (Pridopidine) were likely to generate sales of over $5 billion a year. A report by JP Morgan from November 2015 estimated peak sales of the movement disorders products at over $1.5 billion a year. JP Morgan reiterated this estimate in May 2016.

In order to view Teva's innovate drug portfolio from the proper perspective, it is necessary to consider its sales and profits from Copaxone. Copaxone sales amount to $1 billion a quarter, generating an impressive $816 million operating profit.

Teva's innovative migraine drugs, which are consider potential blockbusters (in pharma industry terms, a blockbuster refers to a drug with projected annual sales of over $1 billion), are in Phase III clinical trials. Results for the drug for treating migraine episodes are expected in the second quarter, while results for the drug for treating chronic migraines a slated for the third quarter of the year.

Teva is expected to submit the two drugs for FDA approval in the fourth quarter of this year, with approval, if granted, likely to come in 2018. Teva is slated to obtain final approval for an innovative drug for treatment of Huntington's Disease in the first quarter of this year. The company also expects to receive final FDA approval in the second quarter for launching a drug for treating tardive dyskinesia (repeated undesirable movements), a drug also regarded as innovative with significant potential.

Published by Globes [online], Israel Business News - www.globes-online.com - on February 19, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Teva  photo: Reuters
Teva photo: Reuters
Unframe founders credit: Yossi Yarom Israeli AI enterprise platform co Unframe raises $50m

Unframe’s turnkey AI solutions enable companies to solve any enterprise AI use case at scale with fully functional, customized AI solutions for businesses in a matter of hours, rather than months.

Combatica credit: Combatica Combatica launches next-gen VR AI training platform

The Israeli company's virtual reality platform includes 50 AI generated scenarios, seven maps and even situations for operating night vision.

Shekel credit: Shutterstock Vladirina 32 Shekel volatility after US tariffs announcement

The shekel is weakening sharply against the euro, which is gaining following the unveiling of Donald Trump's tariffs plan.

Minister of Finance Bezalel Smotrich credit: Noam Moskovitz Knesset Spokesperson Treasury assesses potential damage to Israel's US exports

Israel will be charged a higher tariff on its exports to the US - its biggest export customer - than Turkey and the UAE.

Iranian flag credit: Shutterstock Why inflation haunts Iran

With a month-on-month increase of 3.3% and an annual rate of 37.1%, inflation reflects the struggles of millions of Iranians.

APM merges with lawyers from Doron, Tikotzky Kantor, Gutman credit: Eyal Merilos APM merges with 12 lawyers from Doron, Tikotzky Kantor, Gutman

With the addition of these 12 lawyers, Amit Pollak Matalon & Co. will now have 135 lawyers.

US President Donald Trump credit: Reuters Sipa USA Israel on list as Trump unveils tariffs

Relatively low reciprocal tariffs will be imposed on Israeli goods sold in the US.

Deflated unicorn credit: Shutterstock Big Tech 50 reports more huge falls in startup valuations

Israeli R&D partnership Big Tech 50 reports that an investment of $2 million in Orcam made in 2021, shrank to just $31,000 at the end of 2024.

NextFerm technologies based on yeast credit: NextFerm Food-tech co NextFerm suspends operations

The company, which produces food ingredients in yeast without genetic engineering, cannot pay its debts and is seeking a buyer.

Minister of Finance Bezalel Smotrich credit: Shlomi Yosef OECD sees recovery in growth but high inflation

The OECD Israel Economic Survey 2025 recommends that the Israeli government take several restraining measures, in order to exit the economic storm created by the war.

Dano Ben-Hur credit: Dror Sithakol Statisticians contradict BoI on impact of housing finance deals

The Central Bureau of Statistics insists the impact of 20/80 buy now pay later financing deals on the real estate market and housing prices is minimal.

Governor of the Bank of Israel Amir Yaron  credit: Government Press Office Debt fears top Bank of Israel's concerns

Most unusually, Governor of the Bank of Israel Amir Yaron's press conference last week did not focus on inflation and the impending interest rate decision.

US President Donald Trump  credit: Reuters/Leah Millis Israel moves to avoid Trump's tariffs axe

Minister of Finance Bezalel Smotrich has signed an order canceling all tariffs on imports from the US. The impact will mostly be on agricultural produce.

Forbes Rich List credit: Shutterstock Maslowski Marcin Wiz founders ranked in Forbes 2025 Rich List

There are a few dozen Israelis listed in the 2025 Forbes Real-Time Billionaires List including Wiz founders Assaf Rappaport, Yinon Costica, Roy Reznik and Ami Luttwak.

SatixFy CEO Nir Barkan credit: Ariel Barkan Canada's MDA Space to buy Israeli satcom co SatixFy

MDA Space will pay $269 million for the Israeli company, including taking on a $76 million debt and a 75% premium on SatixFy's closing price on Nasdaq yesterday.

Raising dollars credit: Shutterstock Israeli startups raised over $1b in March

Israeli privately-held tech companies have raised $2.1 billion in the first three months of 2025, according to IVC-LeumiTech, up 24% from the corresponding quarter of 2024.

Twitter Facebook Linkedin RSS Newsletters גלובס Israel Business Conference 2018