Teva (Nasdaq: TEVA) is nonchalant about the brouhaha in the multiple sclerosis drug market, following reports that Serono (NYSE: SRA) is likely to receive earlier than expected approval for its new drug, Rebif. Teva VP Global Product Marketing Dr. Aaron Schwartz told "Globes", "Everything should be taken in proportion."
Schwartz continued, "The only reason why Serono conducted the research is the fact that Biogen's (Nasdaq: BGEN) drug Avonex has the status of an orphan drug. It has market exclusivity until 2003, unless Rebif is proven to be better. The results of the clinical trials published last week show that Rebif outperformed Avonex on every parameter tested during Serono's six-month trial period, which is a brief period, by the way. The results correlated with the expectations of some of the people in the field who believe that interferon-based treatments become more effective as the interferon dosage is increased."
"Avonex contains 30 mg of interferon, while Rebif is made with two dosages, 22 mg and 44 mg. Serono tested the effectiveness of each dosage separately, and found that the higher Rebif dosage was more effective. In the one-on-one trial against Avonex, Rebif was taken at a higher dosage. Meanwhile, Biogen carried out testing that complicates matters. They tested Avonex at 30 mg and 60 mg dosages, and found no difference in the results. In other words, the effect of the dosage remains unknown."
"In any event, even if Rebif enters the market sooner, we're still talking about more than a year from now. Serono could market Rebif without trials in mid-2003. Assuming that Rebif is better than Avonex, they still won't enter the market a year earlier. Maybe they can launch it (just) 3-6 months sooner, because the US Federal Drug Administration (FDA) approval process takes nine months, and Biogen will meanwhile do everything possible to delay Serono's product. A very nasty war is going to break out between the two."
"There's a regulatory question involved: How will the FDA consider Serono's trials. Serono claims they cooperated with the FDA, and convinced them that Rebif is the better product."
"Globes": What is Teva's position on this war?
Schwartz: "Two things can be said about the trial's repercussions on Teva. Firstly, our product isn't interferon, unlike the three products on the market, Avonex, Rebif and Schering-Plough's (NYSE: SGP) Betaseron, so Teva is less involved in the debate. Rebif's entry to the market might hurt Avonex and Betaseron, although Betaseron is declining anyway. However, Betaseron's dosage is similar to Rebif, so its vulnerability -- assuming interferon levels affect a patient's condition -- is unclear."
"It's not impossible that Copaxane sales might be affected, due to market competition. Nevertheless, there will still be people starting multiple sclerosis treatment, who will opt for Teva's Copaxane, because there's uncertainty about interferon dosages. The dosages for Copaxane, in contrast, are clear and the long-term results are proven."
Is a price war over multiple sclerosis drugs possible, especially with the entry of Rebif into the fray?
"The chances of a price war are slim. Serono's global strategy isn't based on price wars. Moreover, Serono will market the higher dosage version in the US, which is 25% costlier than other treatments on the market. I don't foresee them using a lower price as a lever to enter the market."
How is the testing of the oral Copaxone going?
"Testing is progressing as planned. Testing will be completed in the fourth quarter and the results will be published toward the end of the year, or early next year."
If all goes as planned, when will oral Copaxone be on the market?
"We estimate early 2003."
What's the market potential of multiple sclerosis drugs in the US?
"It's hard to say, but the market has passed the $1 billion mark, and may reach $1.5 billion."
Will it stabilize at that level?
"Probably, although there are suggestions that the market is larger than we estimated. We estimated that 70% of patients are receiving treatment, but there are now claims, although I'm uncertain as to their accuracy, that only 60% of patients are actually receiving treatment. In other words, the market potential is greater. In addition, it should be borne in mind that there are patients who don't use existing treatments, but would use an oral treatment."
What's the market potential over the next two years?
"My preliminary estimate was 15%, but Q1 2001 growth was 25%. I estimate growth will be 20% this year."
What will be the growth for Copaxone?
"Growth has been double market growth."
Is there progress in the European market?
"As we reported, we submitted the report on the oral treatment to the EU authorities, and are waiting for approval."
Published by Israel's Business Arena on 25June 2001